Data / Medical devices / United States / Icu Medical, Inc.
Icu Medical, Inc.: FDA-registered device maker in Lake Forest, IL, United States, 114 510(k) clearances
Icu Medical, Inc. is registered with the FDA (registration 3013319212) in Lake Forest, IL, United States. It lists 32 device types. The FDA files 114 510(k) clearances under its listings, the newest dated April 2, 2026. 88 recall events name it as the recalling firm (13 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013319212
- Address
- 600 N Field Dr, Lake Forest, IL, United States, 60045
- Owner or operator
- ICU MEDICAL, INC. (2025816)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- August 4, 1999
- Registered through
- 2026
- Brand names listed
- ADAPTOR, CATHETER, Accessories, pump, infusion, Additive Hinge Cap, Administration Set, Administration Sets: Primary Sets, Extension Sets, Burette Sets, Blood Sets, Advanced Sensor Catheter, Blood Set, Burette Set and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Pump, Infusion | MRZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Adaptor, Catheter | GCE | 1 | Complaint file establishment | accessdata.fda.gov |
| Aid, Transfer | IKX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Complaint file establishment | accessdata.fda.gov |
| Cap, Device Disinfectant | QBP | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Flow Directed | DYG | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Intravascular, Diagnostic | DQO | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FOZ | 2 | Complaint file establishment | accessdata.fda.gov |
| Catheter, Irrigation | GBX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Oximeter, Fiber-Optic | DQE | 2 | Complaint file establishment | accessdata.fda.gov |
| Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System | ONB | 2 | Complaint file establishment | accessdata.fda.gov |
| Container, I.V. | KPE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Device, Warming. Blood And Plasma | KZL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Central Control Unit | ODA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Hemodialysis Catheter Luer End Cap | PEH | 2 | Complaint file establishment | accessdata.fda.gov |
| Infusion Safety Management Software | PHC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment | accessdata.fda.gov |
| Probe, Thermodilution | KRB | 2 | Complaint file establishment | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pump, Infusion, Pca | MEA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Thermal Regulating | DWJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System/Device, Pharmacy Compounding | NEP | 2 | Complaint file establishment | accessdata.fda.gov |
| Transducer, Blood-Pressure, Extravascular | DRS | 2 | Complaint file establishment | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Complaint file establishment | accessdata.fda.gov |
| Tube, Aspirating, Flexible, Connecting | BYY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Warmer, Blood, Non-Electromagnetic Radiation | BSB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 114.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 2, 2026 | K252130 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 2025 | K242117 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 2025 | K242115 | Plum Duo Precision IV Pump | FRN | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 2, 2025 | K242114 | Plum Solo Precision IV Pump | FRN | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| January 22, 2025 | K243985 | Rio Drug Reconstitution Transfer Device | LHI | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 24, 2023 | K223607 | Plum Duo Infusion System | FRN | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 24, 2023 | K223606 | LifeShield Infusion Safety Software Suite | PHC | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 20, 2020 | K192154 | Rio Vial-to-Bag Drug Reconstitution Device | LHI | Substantially Equivalent | Icu Medical | accessdata.fda.gov |
| March 6, 2020 | K190918 | SwabTip Male Disinfectant Cap | QBP | Substantially Equivalent | Icu Medical | accessdata.fda.gov |
| August 10, 2018 | K170110 | Diana Medication Transfer Set | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| May 25, 2018 | K180111 | ClearGuard HD Antimicrobial Barrier Cap | PEH | Substantially Equivalent | Pursuit Vascular, Inc. | accessdata.fda.gov |
| August 25, 2017 | K171346 | Sapphire Sets | MRZ | Substantially Equivalent | Icu Medical | accessdata.fda.gov |
| March 28, 2017 | K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 6, 2017 | K161036 | Hospira Extension Set, Hospira Primary Set | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 6, 2016 | K160492 | Hospira Sapphire Sets | MRZ | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| June 1, 2016 | K160870 | Hospira Administration Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| May 5, 2016 | K152006 | Cogent Hemodynamic Monitoring System | DXQ | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| April 8, 2016 | K143612 | LifeCare PCA Infusion System | MEA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| March 11, 2016 | K160374 | 20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System | FOZ | Substantially Equivalent | Tangent Medical Technologies, Inc. | accessdata.fda.gov |
| January 19, 2016 | K151969 | Hospira Extension Sets | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| March 4, 2015 | K143087 | Hospira Blood Set | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| February 25, 2015 | K143015 | Hospira Primary Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 16, 2015 | K141789 | PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 15, 2015 | K142622 | IV Administration | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 9, 2015 | K142974 | Extension Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 11, 2014 | K141389 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| December 8, 2014 | K142433 | Hospira Extension Set | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| November 25, 2014 | K142367 | Hospira Primary Sets | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| October 28, 2014 | K141686 | EQUATOR CONVECTIVE WARMER, SNUGGLE WARM ADULT FULL BODY CONVECTIVE WARMING BLANKET, SNUGGLE WARM PEDIATRICFULL BODY | DWJ | Substantially Equivalent | Smith Medical Asd, Inc. | accessdata.fda.gov |
| August 5, 2014 | K141834 | SAPPHIRE ADMINISTRATION SET | FPA | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| July 25, 2014 | K141193 | MEDFUSION 4000 PUMP DEVICE SPECIFIC REPORTS SOLFWARE FOR PHARMGUARD SERVER VERSION 2.0 | PHC | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| July 8, 2014 | K141102 | HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| July 2, 2014 | K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | DQE | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| January 24, 2014 | K133602 | ADD-VANTAGE ADDAPTOR | LHI | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 24, 2013 | K130975 | SWABCAP AND SWABFLUSH | QBP | Substantially Equivalent | Excelsior Medical Corp. | accessdata.fda.gov |
| December 9, 2013 | K130394 | CADD -SOLIS AMBULATORY INFUSION PUMP, VERSION 3.0 | MEA | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| October 17, 2013 | K123049 | SAPPHIRE INFUSION PUMP | FRN | Substantially Equivalent | Q Core Medical , Ltd. | accessdata.fda.gov |
| July 26, 2013 | K131549 | CHEMOLOCK, CHEMOLOCK PORT | ONB | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| July 20, 2012 | K120839 | NOVACATH SECURE IV CATHETER SYSTEM-18G | FOZ | Substantially Equivalent | Tangent Medical Technologies, Inc. | accessdata.fda.gov |
| March 5, 2012 | K110901 | SYMBIQ INFUSION AND ADMINSTRATION SET | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 12, 2012 | K113683 | LIFESHIELD VISION INFUSION SET WITH PRE-PIERCED RESEAL | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 7, 2011 | K103224 | HOSPIRA PLUM INFUSION SET; HOSPIRA INFUSION SET WITH YELLOW STRIPE TUBING | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 10, 2010 | K103344 | INFUSION SETS | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 11, 2010 | K101677 | HOSPIRA INFUSION BLOOD SETS | FPA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| September 18, 2009 | K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | DQE | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| June 12, 2009 | K091181 | LOCKBOX FOR USE WITH MEDFUSION 3000 SERIES PUMPS | MRZ | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| March 13, 2009 | K090610 | HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM | DRG | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 17, 2008 | K082783 | CADD -SOLIS MEDICATION SAFETY SOFTWARE: ADMINISTRATOR AND POINT-OF-CARE | MRZ | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| September 11, 2008 | K080579 | EFFECTIV (TM) CAP | QBP | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| July 18, 2008 | K081156 | CADD MEDICATION CASSETTE RESERVOIR | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| June 2, 2008 | K072080 | NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, | LGZ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| April 25, 2008 | K080743 | LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP | FRN | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| March 7, 2008 | K072144 | CADD -SOLIS AMBULATORY INFUSION PUMP AND CADD -SOLIS MEDICATION SAFETY SOFTWARE - ADMINISTRATOR | MEA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| April 24, 2007 | K070398 | HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 4, 2006 | K061450 | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS | DQE | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| August 1, 2006 | K061513 | LEVEL 1 SNUGGLE WARM PEDIATRIC AND LARGE PEDIATRIC UNDERBODY BLANKET | DWJ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| April 21, 2006 | K060806 | HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, 7 THERAPY, MODEL 13087; 6 THERAPY, MODEL 13086; PAIN MANAGEMENT, MODEL 13088 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| February 17, 2006 | K052828 | DISPOSABLE TRANSPAC III INTEGRATED TRANSDUCER (IT) | DRS | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| December 22, 2005 | K052865 | HOSPIRA CATH LAB CONVENIENCE KITS | DQO | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| November 17, 2005 | K051568 | CADD-MS 3 AMBULATORY INFUSION PUMP | FRN | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| August 24, 2005 | K052052 | HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5 | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| January 4, 2005 | K042432 | PHARMGUARD TOOLBOX, MODEL G6000782 | FRN | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| October 18, 2004 | K042800 | LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | MEA | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| September 1, 2004 | K042182 | Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| August 24, 2004 | K042081 | PLUM A+ INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE , AND PLUM A+3 INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE | FRN | Substantially Equivalent | Hospira, Inc. | accessdata.fda.gov |
| May 19, 2004 | K040636 | CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION CASSETTE RESERVOIR WITH FLOW STOP AND EXTENSION SET | FPA | Substantially Equivalent | Smiths Medical MD, Inc. | accessdata.fda.gov |
| April 30, 2004 | K040899 | MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP | FRN | Substantially Equivalent | Medex, Inc. | accessdata.fda.gov |
| April 27, 2004 | K040632 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM, MODEL SW4000 | DWJ | Substantially Equivalent | Smiths Medical Asd, Inc. | accessdata.fda.gov |
| December 4, 2003 | K033576 | LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE | FPA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 23, 2003 | K031361 | CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP | FPA | Substantially Equivalent | Deltec, Inc. | accessdata.fda.gov |
| December 18, 2001 | K011907 | SNUGGLE WARM 4000 CONVECTIVE WARMING SYSTEM | DWJ | Substantially Equivalent | Sims Level 1, Inc. | accessdata.fda.gov |
| June 5, 2001 | K011442 | ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 6, 2001 | K010924 | MODIFICATION TO PLUM XL INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 9, 2000 | K001764 | HOTLINE 2 FLUID WARMER | LGZ | Substantially Equivalent | Sims Level 1, Inc. | accessdata.fda.gov |
| June 8, 2000 | K000842 | CADD-PRIZM PCS II MODEL 6101 AMBULATORY INFUSION SYSTEM | FRN | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| April 27, 2000 | K000942 | CADD CHECKVALVE ADMINISTRATION SET, MODEL 21-7090 | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 15, 1999 | K991599 | CADD ADMINISTRATION SET | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991301 | CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON ANTI-SIPHON VALVE, CADD ADMINISTRATION SET WITH 1 | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 9, 1999 | K991255 | CADD-TPN ADMINISTRATION SET, MODEL 21-7071 | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| February 12, 1999 | K990083 | CADD ADMINISTRATION SET, CADD 250ML FLEXIBLE MEDICATION RESERVOIR, MODIFIED SECURIT SHELL, SECURITY SHELL ADAPTER | FPA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| January 12, 1999 | K982159 | ABBOTT PLUM A+ INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K982838 | CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400 | FRN | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| November 2, 1998 | K982839 | CADD-LEGACY PCA AMBULATORY INFUSION SYSTEM, MODEL 6300 | MEA | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| November 2, 1998 | K982836 | CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM | FRN | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| January 9, 1998 | K973917 | CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM | FRN | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 27, 1997 | K971293 | LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE | FPA | Substantially Equivalent | Abbott Mfg., Inc. | accessdata.fda.gov |
| June 24, 1997 | K970855 | CLAVE CONNECTOR | FPA | Substantially Equivalent | Icu Medical, Inc. | accessdata.fda.gov |
| February 10, 1997 | K961552 | CVP POLYURETHANE CATHETER | FOZ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 23, 1996 | K960826 | CADD-PRIZM MODEL 6100 PUMP | FRN | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| June 4, 1996 | K960957 | EXTERNAL POWER SOURCE (EPS) SYSTEM, POWER PACK | FRN | Substantially Equivalent | Sims Deltec, Inc. | accessdata.fda.gov |
| January 18, 1996 | K952799 | ABBOTT XL3M INFUSION PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 21, 1995 | K943310 | MODEL 6100 AMBULATORY INFUSION SYSTEM | MEA | Substantially Equivalent - Subject to Tracking Reg. | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| October 3, 1994 | K941214 | LIFESHIELD EXTENSION SET | FPK | Substantially Equivalent | Abbott Mfg., Inc. | accessdata.fda.gov |
| June 13, 1994 | K941254 | DYE MANAGEMENT SYSTEM | DQO | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 9, 1994 | K933390 | REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG | FPA | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| April 6, 1992 | K914988 | 500 INFUSER | FRN | Substantially Equivalent | Excel Medical, Inc. | accessdata.fda.gov |
| October 17, 1991 | K911383 | HOTLINE FLUID WARMER | LGZ | Substantially Equivalent | Level 1 Technologies, Inc. | accessdata.fda.gov |
| June 11, 1991 | K911791 | CDD-PCA(TM) MODEL 5800R AMBULATORY INFUSION PUMP | MEA | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
| May 28, 1991 | K911401 | ABBOTT LIFECARE 5000 PUMP | FRN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| September 14, 1990 | K902374 | CADD-TPN MODEL 5700 AMBULATORY INFUSION SYSTEM | FRN | Substantially Equivalent | Pharmacia Deltec, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 20, 2026 | 99648 | Class II | Ongoing | CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-2 | Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus. | accessdata.fda.gov |
| June 10, 2026 | 99192 | Class II | Ongoing | ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump | In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. | accessdata.fda.gov |
| April 29, 2026 | 98872 | Class II | Ongoing | Plum Solo Precision IV Pump, 40001-0401 | Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery. | accessdata.fda.gov |
| December 15, 2025 | 98129 | Class II | Ongoing | Plum Duo Infusion System, List Number 40002-04-01 | ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs. | accessdata.fda.gov |
| December 15, 2025 | 98128 | Class II | Ongoing | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Ha | accessdata.fda.gov |
| November 24, 2025 | 98022 | Class II | Ongoing | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02 | Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-deliver | accessdata.fda.gov |
| November 24, 2025 | 98000 | Class II | Ongoing | LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02 | For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump. | accessdata.fda.gov |
| July 11, 2025 | 97186 | Class I | Ongoing | Plum Duo Infusion System, List Number: 400020401 | ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. | accessdata.fda.gov |
| May 2, 2025 | 96771 | Class II | Ongoing | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 | Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery to patient. 2) An unauthorized user may modify and approve a drug library, potentially leading to incorrect program parameters being used for | accessdata.fda.gov |
| April 22, 2025 | 96777 | Class II | Ongoing | ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001, and 3) 400021003; infusion pump | Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight o | accessdata.fda.gov |
| October 22, 2024 | 95586 | Class I | Ongoing | Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 1197 | ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that thes | accessdata.fda.gov |
| May 7, 2024 | 94690 | Class I | Ongoing | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusin Plum 360 com | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected. | accessdata.fda.gov |
| July 13, 2023 | 92630 | Class II | Ongoing | Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 3001 | Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions. | accessdata.fda.gov |
| March 22, 2023 | 91874 | Class I | Ongoing | Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected. | accessdata.fda.gov |
| July 29, 2019 | 83549 | Class II | Terminated | Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resista | Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets. | accessdata.fda.gov |
| November 8, 2018 | 81615 | Class II | Terminated | SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets | There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets. | accessdata.fda.gov |
| August 1, 2018 | 83480 | Class II | Terminated | Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump. | A software malfunction of the infuser when used with a MedNet Custom Drug Library (CDL). When a new CDL is downloaded and installed on the infuser the infuser can become inoperable and show a blank screen on the User Interface. | accessdata.fda.gov |
| October 30, 2017 | 78418 | Class II | Terminated | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Med | Issue 1: The MedNet Meds 6.1 and 6.21 programs, under certain conditions, can change the piggyback medication entry set settings for existing defined medication entries. This includes (a) whether a medication may be piggybacked and (b) whether an infusion may be interrupted by a piggyback. This only occurs when: 1. Medication entries are built with the same | accessdata.fda.gov |
| October 30, 2017 | 78312 | Class II | Terminated | Plum 360 Infusion System, List number 30010. | (1) Under certain conditions, if a malfunction alarm occurs while the pump is in the "Paused" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total | accessdata.fda.gov |
| June 15, 2017 | 77624 | Class II | Terminated | Plum 360 Infusion System | Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion. | accessdata.fda.gov |
| December 30, 2016 | 76253 | Class II | Terminated | Plum 360 Infusion Pump, Software Version 15.02. The infusion pump is capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions | Depleted Battery alarm shows instead of Replace Battery. On battery power, ongoing therapy stops, alarms show and sound, pump shuts down after 3 minutes. On AC power, the pump reboots (takes about 25 seconds). Therapy can resume. AC power interruption of 3-7 seconds prompts an incorrect E323 alarm, ongoing therapy stop, and pump reboot. Longer power loss res | accessdata.fda.gov |
| July 28, 2016 | 74903 | Class II | Terminated | Hospira MedNet Medication Management Suite software, version 6.1, List Numbers 16037-64-02 and 16037-64-03, in combination with the SapphirePlus 13.1x infusion pump Hospira MedNet Medication Management Suite is intended | Hospira MedNet 6.1 software, in combination with the SapphirePlus 13.1x infusion pump, may result in incorrect bolus amount calculations for drugs whose concentrations are listed in Million Units. | accessdata.fda.gov |
| March 25, 2016 | 73799 | Class II | Terminated | The Plum 360 is a large volume infuser capable of delivering fluids for a variety of therapies such as parenteral, enteral, or epidural infusions. The Plum 360 infuser can deliver fluids over a broad range of infusion ra | Firm's investigation determined that the Proximal Occlusion Alarms observed in the field were attributed to the mechanism calibration process being performed with an out of specification metal cassette, resulting in an offset in proximal pressure. | accessdata.fda.gov |
| December 22, 2015 | 73104 | Class II | Terminated | The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-ac | Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. | accessdata.fda.gov |
| July 2, 2014 | 69336 | Class I | Terminated | The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. | accessdata.fda.gov |
| June 11, 2014 | 68672 | Class II | Terminated | Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Assembly Part Number 820-95443-008. A cassette based multi-function infusion system. Each system includes a pumping module and an assortment of dis | Plum A+ infusion system pole clamp assemblies were discovered to be cracked. If the knob on the pole clamp assembly is cracked, the infuser cannot be attached to the IV pole since the knob is used to tighten and loosen the grip of the pole clamp to the pole. | accessdata.fda.gov |
| June 6, 2014 | 68658 | Class II | Terminated | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hosp | Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of "nanog/kg/min" and "milliUnits/min" are not sent to a Plum A+ device (Version 13.40, 13.41, and 13.4.2) via Auto Programming when those dosing units are not properly established in the customized drug library. A dosing unit mismatch of "nanog/kg/min" or "milliUnits/min" o | accessdata.fda.gov |
| March 25, 2014 | 68129 | Class II | Terminated | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder | The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Lat | accessdata.fda.gov |
| February 25, 2014 | 67722 | Class II | Terminated | LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inch with Prepierced Reseals, OPTION-LOK and Inline Dual Channel Cassette. For administration of blood and blood bags for use with Plum Series Inf | Hospira identified an incorrect lower lid (set component) had been supplied and was being used during the manufacturing process of list number 11241-03, a HemoSet containing a burette and blood filter, intended for infusion of blood/blood products. In a gravity delivery, the correct lower lid dispenses 15 drops per mL and the incorrect lower lid found dispen | accessdata.fda.gov |
| February 18, 2014 | 67802 | Class I | Terminated | GemStar Docking Station, used with GemStar infusion pump, in combination with other GemStar accessories such as the GemStar Lock Box and patient bolus cord. The docking station is also used for hosting the GemStar pump f | There are two situations that may occur when using the GemStar Docking Station, List Number 13075-XX-XX, in conjunction with the GemStar infusion pump: 1) when the Docking Station is used in conjunction with a GemStar Phase 3 pump (List 13000-XX, 13100-XX, or 13150-XX) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to t | accessdata.fda.gov |
| February 3, 2014 | 68047 | Class I | Terminated | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is a two piece assembled switching power supply. The Power Supply converts alternating current (AC) line input voltage of 120 or 240 V to an outp | The GemStar Infusion pump may not receive direct current (DC) power from the power supply. In one instance, smoke was observed and the GemStar pump was operating on battery power while connected to the 3 volt DC power supply. | accessdata.fda.gov |
| January 31, 2014 | 68200 | Class II | Terminated | GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150. Used for intravenous, arterial, subcutaneous, short-term epidural infusion and parenteral administration of | The connection between the beeper subassembly and the pump may fail. The GemStar infusion pump will identify this failure during the "self-test" while powering up which will result in a Beeper Error ("code 10/001/000"). This Beeper Error (code 10/001/000) is a service alarm that places the pump in an inoperable mode and requires service before it can be retu | accessdata.fda.gov |
| January 24, 2014 | 67453 | Class II | Terminated | LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration. | There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a c | accessdata.fda.gov |
| October 31, 2013 | 67591 | Class I | Terminated | Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. | Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy. | accessdata.fda.gov |
| October 25, 2013 | 67038 | Class II | Terminated | 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE HEMA; Y-TYPE BLOOD SET, Nonvented, 88 Inch with 210 Micron Filter Pump, Prepierced Injection Site and Secure Lock; Made in Costa Rica; Product Inqu | Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administration Set were assembled incorrectly. | accessdata.fda.gov |
| September 10, 2013 | 66448 | Class II | Terminated | Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, ATS, 2000, with Valve 1) List Numbers 43449-01 and 43449-11; LIST NO. 43449 RECEPTAL CANISTER; CANISTER FOR REUSE, THROW AWAY LINER ONLY; DO NOT | Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent. | accessdata.fda.gov |
| September 9, 2013 | 66372 | Class II | Terminated | 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUM | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets. | accessdata.fda.gov |
| August 28, 2013 | 66263 | Class II | Terminated | 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; *** E09 batteries can be identified by the "E09" that is printed beneath the bar code and at the end of the serial number along the bottom of the label fo | Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the correct E09 battery pack (Part No. HSP3566-E09) for the Symbiq Single and Dual Channel Infusers. | accessdata.fda.gov |
| July 17, 2013 | 66431 | Class II | Terminated | Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. Used to isolate suction waste during surgeries, or to clear pat | Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating. | accessdata.fda.gov |
| June 18, 2013 | 65647 | Class II | Terminated | LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE PIN, PIGGYBACK, 2 CLAVES PORTS AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 97 IN (249 CM); PRIMING VOLUME: 14 ML; For the administration of I.V. | Hospira has received reports of customers experiencing air-in-line alarms related to administration sets that have a drip chamber with a ball valve. Preliminary investigation findings found that there is a potential for the ball valve to not seal the drip chamber as intended, leading to air in the line of the administration set. | accessdata.fda.gov |
| April 1, 2013 | 65689 | Class I | Terminated | List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP; For Blood Product Administration; Made in Costa Rica; Product Inquiries should be directed to Hospira., Inc., Lake Forrest, IL 60045 USA Hospi | It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag. | accessdata.fda.gov |
| March 21, 2013 | 64841 | Class II | Terminated | The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturing additional medication resulting in over-infusion. | accessdata.fda.gov |
| March 19, 2013 | 69505 | Class II | Terminated | GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (pain management) list number 13150. Product Usage The pump is suitable for intravenous, arterial, subcutaneous, short-term epidural infusion and | Some patients are obtaining access to the dosage reset codes required to change the settings on GemStar infusion pumps and are subsequently changing the infusion rate set by their doctors. Patients are obtaining access to these codes via website sponsors by downloading the GemStar User/Service Manual featured on the sponsors' websites. The GemStar User/Servi | accessdata.fda.gov |
| March 18, 2013 | 64839 | Class I | Terminated | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pu | Battery level lower then 2.4 volts results in corrupt history log and loss of data for preview therapy's parameters and causes an 11/004 error resulting in the pump not being able to be used. | accessdata.fda.gov |
| March 18, 2013 | 64837 | Class I | Terminated | The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, | Pump shutting off during use without warning. | accessdata.fda.gov |
| March 15, 2013 | 64832 | Class I | Terminated | The GemStar Pump is a small and lightweight, single channel infusion device designed for use in the home, in the hospital, or anywhere electronic infusion is required. The GemStar Pump can be powered by AC mains adaptor, | The proximal and distal pressure sensor calibration can drift resulting in the pump failing the Proximal or Distal Occlusion Operational Test, as described in the GemStar Technical Service Manual, or reporting one of the following errors during device setup or infusion: 1) Cassette Check - D; 2) Cassette Check - P; 3) Proximal Occlusion; 4) Distal Occlusion; | accessdata.fda.gov |
| March 8, 2013 | 68318 | Class II | Terminated | The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, tra | Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion. | accessdata.fda.gov |
| March 8, 2013 | 64230 | Class II | Terminated | LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications. | Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops. | accessdata.fda.gov |
| February 27, 2013 | 64225 | Class II | Terminated | The PCA 3 infusion pump allows clinicians, or patients, to (self) Administer analgesia safely and effectively within clinician programmed limits. | The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication. | accessdata.fda.gov |
| February 19, 2013 | 64220 | Class II | Terminated | Minibore Extension Set, 59 Inch with Spin Lock Collar, Non-DEHP, Latex-Free Intended use: For the administration of drugs and solutions to a patient's vascular system through a vascular access device. | Hospira, Inc. is voluntarily recalling one lot of list 14699-28, Minibore Extension Set, 59 inch with Spin Lock Collar, Non-DEHP, identified above due to a confirmed customer report of an occlusion of solvent in the male luer lock. This occlusion has the potential to prevent the set from being primed for use and cause a delay in therapy. | accessdata.fda.gov |
| February 6, 2013 | 64261 | Class II | Terminated | Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. T | The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. | accessdata.fda.gov |
| February 5, 2013 | 63993 | Class II | Terminated | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026 | Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequen | accessdata.fda.gov |
| February 4, 2013 | 65610 | Class II | Terminated | The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous | The devices secondary audio signal fails to activate. | accessdata.fda.gov |
| February 4, 2013 | 63994 | Class II | Terminated | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolyt | Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein Open (KVO) delivery. This can allow the clinician to select the "NEXT" button prior to completion of the programming. If this error occurs, a delay in therapy could occur and potentially result in significant injury. | accessdata.fda.gov |
| February 4, 2013 | 63990 | Class II | Terminated | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolyt | Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump. | accessdata.fda.gov |
| February 1, 2013 | 64542 | Class II | Terminated | The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, m | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. | accessdata.fda.gov |
| February 1, 2013 | 64263 | Class II | Terminated | The Plum A+ Hyperbaric Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Hyperbaric I | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspecti | accessdata.fda.gov |
| December 7, 2012 | 63772 | Class II | Terminated | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971; b) list 11973 - software version 10.3; c) list 12391 - software version | The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. | accessdata.fda.gov |
| October 26, 2012 | 63518 | Class II | Terminated | Plum A+ Single Channel Infusion Pumps with Plug-and-Play Modules that provide wired Ethernet and wireless local area networking; Hospira, Inc., Lake Forest, IL 60045; pump list number 11971, module list numbers 12101, 12 | The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a clockwise rotation of the knob decreases the volume; however, on some of the devices the alarm volume increases when the kn | accessdata.fda.gov |
| August 29, 2012 | 63056 | Class I | Terminated | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump | The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed v | accessdata.fda.gov |
| August 28, 2012 | 63078 | Class II | Terminated | Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections. | Embedded iron oxide glass defect which may have the potential to break off into the solution. | accessdata.fda.gov |
| August 2, 2012 | 62909 | Class II | Terminated | Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device. | Reports of leaking during filling and administration. | accessdata.fda.gov |
| July 13, 2012 | 62582 | Class II | Terminated | Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical devi | The float valve in the burette sticks to the burette wall and does not open or close properly. | accessdata.fda.gov |
| April 25, 2012 | 61680 | Not yet classified | Terminated | LifeShield Primary Plumset, CLAVE port, CLAVE Y-Site, 104 inch, 15 drops/mL, 48 sets per case; a sterile Rx device; Hospira Inc, Lake Forest, IL USA. Made in Costa Rica; product 120300412, list number 12030-12. Product U | The Lifeshield Primary Plumsets may cause a cassette test failure alarm when the set is loaded onto the infusion pump. A set which results in a cassette test failure alarm may result in delay in therapy, requiring medical intervention. | accessdata.fda.gov |
| March 28, 2012 | 61472 | Not yet classified | Terminated | GemStar Bolus Cord; a remote bolus cord and switch for use with GemStar 7 Therapy and Pain Management Pumps, list 13000, 13150, 13087 and 13088; Hospira, Inc., Lake Forest, IL 60045; List Number 13027; An accessory for t | Hospira has received customer reports of bolus delivery failures when using the GemStar bolus cord. Possible failures may be a result of cracked or damaged bolus cords which may result in an open or short circuit of the Bolus Cord. | accessdata.fda.gov |
| February 5, 2012 | 64091 | Class II | Terminated | Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part: PLUM A+ HYPERBARIC; Product Usage: The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therap | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, users may experience false distal occlusion a | accessdata.fda.gov |
| January 12, 2012 | 60869 | Not yet classified | Terminated | Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to administer blood products; 48 individually wrapped sets per case; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 6004 | Silicone applied to the piercing pin of the blood set is reducing retention force of the piercing pin while in use. This could cause the piercing pin to slip out of the administration container. | accessdata.fda.gov |
| November 18, 2011 | 60504 | Not yet classified | Terminated | 0.9% Sodium Chloride Injection, USP, pre-filled flush solution, for IV Flush only, sterile fluid path; 10 mL Single-Use Syringe with Male Luer Lock, 100 syringes per pack, 4 packs per case; Made in Costa Rica, Hospira, I | There is particulate matter in the fluid pathway, which has been identified as the same material as the rubber tip of the syringe plunger. | accessdata.fda.gov |
| November 10, 2011 | 60413 | Not yet classified | Terminated | Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convertible Pin, 77 inch, Soluset Microdrip with Option-Lok; an Rx sterile medical device used to administer fluids; 20 individ | The float valve in the burette sticks to the burette wall and does not open or close properly. | accessdata.fda.gov |
| September 16, 2011 | 59956 | Not yet classified | Terminated | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11 | Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This condition could cause a delay in therapy if the clinician is unable to start the device due to the continuous recycling and/ | accessdata.fda.gov |
| September 16, 2011 | 59953 | Not yet classified | Terminated | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11 | Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged the clamp prior to opening the cassette door, unrestricted flow may occur. | accessdata.fda.gov |
| August 1, 2011 | 59470 | Not yet classified | Terminated | GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13 | Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station. | accessdata.fda.gov |
| March 28, 2011 | 58276 | Not yet classified | Terminated | Hospira Latex-Free Blood Secondary Set, 26 Inch with Secure Lock; a sterile Rx tubing set for the administration of fluids from a blood bag in series with an I.V. solution bottle and I.V. set; Made in Costa Rica; Hospira | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. | accessdata.fda.gov |
| March 23, 2011 | 58202 | Not yet classified | Terminated | GemStar SP Infusion Suite Database, Version 1.0; an Rx PC software application; Hospira, Inc., Lake Forest, IL 60045; list 13092-04-01 A stand-alone PC application for administration of medications specific to the GemSta | The software enables programming of the GemStar device for a Bolus Lower Lockout Limit outside of the hard limits entered into the GemStar SP Infusion Suite Database PC application. | accessdata.fda.gov |
| March 16, 2011 | 64005 | Class II | Terminated | Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids. List number 16026. Note that Hospira retired this pump June 30, 2015. The Hospira Symbiq Infusion System is intended for the | May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic screen displayed to the user as part of the safety shutdown procedure of the device. The infusion and the processor stop, sound a 3 minute audible alarm from the backup buzzer and deactivate the couch screen and the automated loading/unloading of cassettes. Delay o | accessdata.fda.gov |
| February 14, 2011 | 57724 | Not yet classified | Terminated | Plum A+ Single Channel Infusion Pumps; Hospira, Inc., Lake Forest, IL 60045; the pumps were sold under the following configurations: a) list 11971 b) list 11973 - software version 10.3 c) list 12391 - software version 11 | Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues. | accessdata.fda.gov |
| February 14, 2011 | 57697 | Not yet classified | Terminated | Hospira Plum XL Infusion Pump, Single Channel; list number 11555 | Hospira has received reports of the Plum XL, XLM and XLD Infusion Pumps with no audible alarm at the low audio level setting. | accessdata.fda.gov |
| August 12, 2010 | 56505 | Not yet classified | Terminated | Gemstar Pump Set, Latex-Free Extension Set with Integral Pressure-Activated Anti-Siphon Valve and Y-Extension with Backcheck Valve-SL, Nonvented, 110 inch; Rx, sterile, 24 individually packaged sets per case; Hospira, In | Underdelivery of infusion during clinical use at low rate settings (less than 10 mL/hour). Patient may not receive the intended amount of medication. | accessdata.fda.gov |
| July 26, 2010 | 56730 | Not yet classified | Terminated | EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5 | The EndoTool software did not always provide an audible alert when a blood glucose measurement was due. This could result in a patient not receiving an appropriate dose of insulin. | accessdata.fda.gov |
| January 8, 2010 | 54195 | Not yet classified | Terminated | LifeShield Latex-Free Primary SYMBIQ Set, Piggyback with Backcheck Valve, 3 Prepierced Y-Sites, 106 inch, Non-DEHP, 15 drops/mL; an Rx sterile single use fluid path way for administration of I.V. fluids using the Symbiq | There is a potential for fluid to leak from the backcheck valve which could result in inaccurate delivery and occupational exposure. | accessdata.fda.gov |
| November 24, 2009 | 54080 | Not yet classified | Terminated | Latex-Free Symbiq Pump Set, convertible pin, 106 inch piggyback with backcheck valve, 2 CLAVE ports, distal microbore tubing and OPTION-LOK, MICRODRIP, non-DEHP 60 drops/mL; a sterile single patient use Rx device; Hospir | Company has confirmed reports of backflow of fluid past the backcheck valve on Symbiq administration sets. | accessdata.fda.gov |
| November 24, 2009 | 54079 | Not yet classified | Terminated | Lifeshield, latex-free 100mL Burette Set, convertible pin, 77 inch with 2 pre-pierced injection sites and OPTION-LOK MICRODRIP SOLUSET, 60 drops/mL, a sterile Rx single use device, Hospira Inc, Lake Forest, IL USA. Made | Reports of difficulty in adjusting the flow rate, which could result in flow rate variances. | accessdata.fda.gov |
| January 3, 2008 | 46846 | Not yet classified | Terminated | Hospira LifeCare PCA Label Utility, Version 1.0 CD. The installation/user guide is entitled "LifeCare PCA Barcode Label Utility Program." This software program is designed to allow entry of each drug concentration into a | Incorrect dosage labels created: Customers have experienced independent changes in drug concentration (mg/mL to mcg/mL and vice versa) and expiration dates, and the addition of trailing zeros to the barcodes. | accessdata.fda.gov |
| December 20, 2006 | 37014 | Not yet classified | Terminated | LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and | The tubing can separate from the set at the filter inlet post. | accessdata.fda.gov |
| January 9, 2006 | 34354 | Not yet classified | Terminated | Hospira Latex Free Blood Secondary Set, 26 inch with Secure Lock; Made in Costa Rica, Hospira, Inc., Lake Forest, IL 60045 U.S.A. | The I.V. administrations sets were stolen in-transit between the manufacturing site and the sterilizer, resulting in non-sterilized product possibly being on the market. | accessdata.fda.gov |
| September 29, 2005 | 33659 | Not yet classified | Terminated | LifeShield Latex-Free HEMA Blood PlumSet; Nonvented, 100 inch, with 210 Micron Filter, Prepierced Injection Site and Option-Lok, Dual Channel Capped Secondary Port; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa | Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. | accessdata.fda.gov |
| May 6, 2005 | 31990 | Not yet classified | Terminated | LifeShield Latex-Free HEMA Blood PlumSet, Nonvented, 110 Inch with 210 Micron Filter, Prepierced Injection Site and OPTION-LOK, Dual Channel, Capped Secondary Port; a sterile Rx blood administration set for use with the | Inlet and outlet tubing on the cassette may be reversed, which would result in reverse flow. | accessdata.fda.gov |
| November 2, 2004 | 30478 | Not yet classified | Terminated | Angiographic Syringe, 10 cc Thumb Ring with Rotator Reservoir. | Syringes could possibly allow air to enter the patient's vascular system. | accessdata.fda.gov |
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Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.