Data / Medical devices / United States / Cardinal Health 200, LLC
Cardinal Health 200, LLC: FDA-registered device maker in Waukegan, IL, United States, 276 510(k) clearances and 1 PMA approval
Cardinal Health 200, LLC is registered with the FDA (registration 1423537) in Waukegan, IL, United States. It lists 483 device types. The FDA files 276 510(k) clearances and 1 PMA approval under its listings, the newest dated September 2, 2026. 82 recall events name it as the recalling firm (5 Class I). Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1423537
- FEI number
- 3001236905
- Address
- 3651 Birchwood Drive, Waukegan, IL, United States, 60085
- Owner or operator
- Cardinal Health 200, LLC (9028292)
- Roles
- Complaint file establishment
- First device listed
- December 23, 1977
- Registered through
- 2027
- Brand names listed
- CARDINAL HEALTH NITRILE EXAMINATION GLOVES EXTENDED CUFF, Stainless Steel Tongue Cleaner
Devices it lists
83 more device types in the FDA listing
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 276.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 2, 2026 | K261749 | Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate | LZA | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| April 28, 2026 | K253243 | Cardinal Health Poly Reinforced Surgical Gown | FYA | Substantially Equivalent | Cardinal Health 200, LLC | accessdata.fda.gov |
| January 14, 2026 | K252313 | Cardinal Health Nitrile Examination Gloves Extended Cuff | LZC | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| August 22, 2025 | K243660 | Monoject 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject 3mL Syringe, Luer-Lock Tip (1180300777); Monoject 6mL Syringe, Luer-Lock Tip (1180600777); Monoject 12mL Syringe, Luer-Lock Tip (1181200777); Monoject 20mL Syringe, Luer-Lock Tip (1182000777); Monoject 35mL Syringe, Luer-Lock Tip (1183500777); Monoject 60mL Syringe, Luer-Lock Tip (1186000777); Monoject 3mL Syringe, Luer-Lock Tip (8881513934); Monoject 6mL Syringe , Luer-Lock Tip (8881516937); Monojec | FMF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| December 19, 2024 | K243652 | Monoject Enteral Syringe with ENFit Connector (401SE); Monoject Enteral Syringe with ENFit Connector (403SE); Monoject Enteral Syringe with ENFit Connector (406SE); Monoject Enteral Syringe with ENFit Connector (412SE); Monoject Enteral Syringe with ENFit Connector (435SE); Monoject Enteral Syringe with ENFit Connector (460SE) | PNR | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| August 23, 2024 | K241780 | Cardinal Health Nitrile Exam Gloves | LZA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| July 27, 2023 | K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | FYA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| July 3, 2023 | K230569 | Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ); Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 1 ) | FXX | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| June 21, 2023 | K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130) | MEG | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| April 3, 2023 | K230028 | Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly | JOW | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| December 20, 2022 | K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI | LZH | Substantially Equivalent | Cardinal Health, LLC | accessdata.fda.gov |
| May 19, 2022 | K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | PIF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| November 23, 2021 | K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown | FYA | Substantially Equivalent | Cardinal Health, LLC | accessdata.fda.gov |
| September 26, 2021 | K201592 | Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove | KGO | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| June 4, 2021 | K202217 | Kendall NPWT Incision Management Device | OMP | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| July 31, 2020 | K191101 | Kendall NPWT Incision Management Dressing Kit | OMP | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| July 29, 2020 | K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | FYA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| March 20, 2020 | K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | FYA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| December 2, 2019 | K192374 | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip | FXX | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| November 7, 2019 | K190923 | Salem Sump Dual Lumen Stomach Tube with ENFit Connection | PIF | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| April 26, 2019 | K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | QPC | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| December 11, 2018 | K181174 | Cardinal Health Sterilization Wrap | FRG | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| October 23, 2018 | K180622 | Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port | KNT | Substantially Equivalent | Covidien | accessdata.fda.gov |
| June 13, 2018 | K181363 | EcoVue Sterile and Non-Sterile Ultrasound Gels | MUI | Substantially Equivalent | H R Pharmaceuticals, Inc. | accessdata.fda.gov |
| January 31, 2018 | K173601 | Merit Syringe | FMF | Substantially Equivalent | Merit Medical Systems, Inc. | accessdata.fda.gov |
| November 3, 2017 | K170965 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Shenzhen Jumper Medical Equipment Co., Ltd. | accessdata.fda.gov |
| September 22, 2017 | K171499 | Occlusion Detection Dressing Kit | OMP | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| June 9, 2017 | K170762 | Cardinal Health Non-Reinforced Surgical Gown | FYA | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| May 16, 2017 | K163002 | Kangaroo Feeding Tube with IRIS Technology | KNT | Substantially Equivalent | Covidien (Dba Medtronic) | accessdata.fda.gov |
| January 19, 2017 | K163620 | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| January 19, 2017 | K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set | OMP | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| December 23, 2016 | K163055 | Reprocessed Kendall SCD Express Foot Cuff | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 14, 2016 | K161886 | Transtek Blood Pressure Monitor, Welch Allyn Remote Monitoring Blood Pressure Device, Welch Allyn Home Blood Pressure Device | DXN | Substantially Equivalent | Guangdong Transtek Medical Electronics Co., Ltd. | accessdata.fda.gov |
| September 1, 2016 | K161963 | Monoject Enteral Syringe with ENFit Connector | PNR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 28, 2016 | K160339 | Cardinal Health Isolation Gown | FYC | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| July 11, 2016 | K160875 | Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| July 6, 2016 | K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal | LZH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 12, 2016 | K160419 | Monoject Enteral Feeding Syringe with ENFit Connector | PNR | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 12, 2016 | K153316 | Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow) | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| March 24, 2016 | K151778 | Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating | KGO | Substantially Equivalent | Cardinal Health 200, Inc. | accessdata.fda.gov |
| October 8, 2015 | K150711 | Salem Sump Dual Lumen Stomach Tube with Multi-functional Port | PIF | Substantially Equivalent | Covidien | accessdata.fda.gov |
| July 13, 2015 | K150084 | Argyle¿ Polyvinyl Chloride (PVC) and Kangaroo¿ Polyurethane (PU) Neonatal and Pediatric Feeding Tubes with ENFit connector | PIF | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 29, 2015 | K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets | LZH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| May 21, 2015 | K150151 | SmartGownTM surgical gown | FYA | Substantially Equivalent | Cardinal Health 200, Inc. | accessdata.fda.gov |
| April 20, 2015 | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | OMP | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| April 2, 2015 | K143018 | Kangaroo Enteral Feeding Tube Extension Set with ENFit Small Bore Connectors | PIF | Substantially Equivalent | Covidien | accessdata.fda.gov |
| March 4, 2015 | K142990 | Insta-Gard Surgical and Procedure Face Mask | FXX | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| March 4, 2015 | K142916 | SVED Wound Treatment System | OMP | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| December 23, 2014 | K141479 | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS | LZH | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 17, 2014 | K140581 | CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT TRANSITION CONNECTOR FOR MEDICATION PORT | PIO | Substantially Equivalent | Cedic S.R.L. | accessdata.fda.gov |
| June 20, 2014 | K140155 | SECURE-GARD SURGICAL AND PROCEDURE FACE MASK | FXX | Substantially Equivalent | Cardinal Health200, LLC | accessdata.fda.gov |
| April 9, 2014 | K123555 | KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY | KNT | Substantially Equivalent | Covidien | accessdata.fda.gov |
| December 6, 2013 | K133356 | PROLENE POLYPROPYLENE NONABSORBABLE SUTURE | GAW | Substantially Equivalent | ETHICON, Inc. | accessdata.fda.gov |
| November 5, 2013 | K132567 | ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN | LJS | Substantially Equivalent | Covidien | accessdata.fda.gov |
| September 11, 2013 | K131021 | PULSE OXIMETER | DQA | Substantially Equivalent | Nonin Medical, Inc. | accessdata.fda.gov |
| August 27, 2013 | K132360 | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| April 17, 2013 | K130725 | MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR. | FOS | Substantially Equivalent | Covidien Lp, Formerly Registered AS Kendall | accessdata.fda.gov |
| May 11, 2012 | K112511 | DOBBHOFF DUAL PORT FEEDING TUBE | KNT | Substantially Equivalent | Covidien Lp, Formerly Registered AS Kendall | accessdata.fda.gov |
| April 27, 2012 | K113707 | STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| January 31, 2012 | K120058 | TRANSTEK BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Zhongshan Transtek Electronics Co., Ltd. | accessdata.fda.gov |
| September 29, 2011 | K111878 | PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| September 21, 2011 | K111868 | STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING | KGO | Substantially Equivalent | Cardinal Health-Medical Products and Services | accessdata.fda.gov |
| June 8, 2011 | K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 6, 2011 | K111015 | STERILE LATEX POWDER FREE SURGICAL GLOVES WITH HYDROGEL COATING | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| April 15, 2011 | K110921 | NITRILE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS | LZA | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| December 16, 2010 | K103249 | NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUG LABELING CLAIM | LZA | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| October 15, 2010 | K101811 | PROTEGRITY SMT LATEX SURGICALGLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| May 4, 2010 | K100306 | KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES | JOW | Substantially Equivalent | Covidien | accessdata.fda.gov |
| October 30, 2009 | K093300 | ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| September 23, 2009 | K091060 | VESOCCLUDE LIGATING CLIP | FZP | Substantially Equivalent | Vesocclude Medical, LLC | accessdata.fda.gov |
| September 15, 2009 | K092304 | ESTEEM ORTHO POLYISOPRENE POWDER-FREE SURGICAL GLOVES | KGO | Substantially Equivalent | Cardinal Health, Inc. | accessdata.fda.gov |
| April 21, 2009 | K083350 | TENS/NMES/FES STIMULATING ELECTRODE | GXY | Substantially Equivalent | Covidien LP | accessdata.fda.gov |
| February 26, 2009 | K082296 | COPA AMD | FRO | Substantially Equivalent | Covidien Lp, Formerly Registered AS Tyco Healthcar | accessdata.fda.gov |
| February 1, 2008 | K071866 | NTRAINER SYSTEM | HCC | Substantially Equivalent | Kcbiomedix, Inc. | accessdata.fda.gov |
| October 16, 2007 | K071049 | DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR | EZL | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| September 14, 2007 | K070685 | KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| September 12, 2007 | K070653 | KENDALL KERLIX ANTIMICROBIAL SUPER SPONGE DRESSING FOR OTC USE, MODEL 6662 | FRO | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| May 18, 2007 | K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | HIB | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| August 3, 2006 | K061492 | MONOJECT MAGELLAN INSULIN AND TUBERCULIN SAFETY SYRINGE | FMF | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| June 5, 2006 | K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N | FYA | Substantially Equivalent | Cardinal Health 200, Inc. | accessdata.fda.gov |
| May 22, 2006 | K060649 | GENIUS 2 INFRARED TYMPANIC ELECTRONIC THERMOMETER, MODEL 303000 | FLL | Substantially Equivalent | Tyco Healthcare Group LP | accessdata.fda.gov |
| October 13, 2005 | K051805 | KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE | JOW | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| January 18, 2005 | K042709 | DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER | EZL | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| November 5, 2004 | K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR | KNT | Substantially Equivalent | Kendall | accessdata.fda.gov |
| July 20, 2004 | K040897 | DOVER ROB-NEL CATHETER | KOD | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| July 15, 2004 | K040649 | KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE | JOW | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| July 7, 2004 | K041243 | DOVER RED RUBBER ROBINSON CATHETER | KOD | Substantially Equivalent | Tyco Healthcare | accessdata.fda.gov |
| June 28, 2004 | K040511 | SCD EXPRESS PORTABLE COMPRESSION SYSTEM | JOW | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| May 17, 2004 | K040388 | NEXT GENERATION SALEM SUMP | FEG | Substantially Equivalent | Kendall | accessdata.fda.gov |
| May 5, 2004 | K040196 | KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS | LZH | Substantially Equivalent | Tyco Healthcare/Kendall | accessdata.fda.gov |
| April 27, 2004 | K033905 | PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING | KGO | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| April 9, 2004 | K040052 | FINE SURGICAL CIRCUMCISION CLAMP | HFX | Substantially Equivalent | Fine Surgical Instrument Corp. | accessdata.fda.gov |
| November 13, 2003 | K032444 | NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY | LZC | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| October 15, 2003 | K031301 | ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING | KGO | Substantially Equivalent | Cardinalhealth | accessdata.fda.gov |
| June 11, 2003 | K024010 | DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER | EZL | Substantially Equivalent | The Kendall Company Div. of Tyco Healthcare Group | accessdata.fda.gov |
| March 7, 2003 | K030339 | CAUTERY TIP CLEANER, MODEL-TC-100 | GEI | Substantially Equivalent | Aspen Surgical Products, Inc. | accessdata.fda.gov |
| October 11, 2002 | K022765 | NITRILE POWDER-FREE EXAMINATION GLOVES | LZA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| October 2, 2002 | K023167 | BREATHABLE SURGICAL GOWN | FYA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
| July 3, 2002 | K021094 | INTROCAN SAFETY IV CATHETER | DYB | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| March 18, 2002 | K020593 | CONVERTORS SMS POLYOLEFIN GOWN | FYA | Substantially Equivalent | Allegiance Healthcare Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 7, 2020 | P190007 | Cardinal Health Multifunctional Defibrillation Electrode | MKJ | 0 | August 7, 2020 | 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 19, 2026 | 99801 | Class II | Ongoing | Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336 | Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspir | accessdata.fda.gov |
| August 18, 2026 | 99768 | Class II | Ongoing | Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE, Catalog Number: PGCGLCBAC; 2) KIT, LAP CHOLE, Catalog Number: PGCGLCBAD; 3) KIT, LAP CHOLE, Catalog Number: PGCGLCBAE; 4) KIT, LAP C | The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the floor. The impact can range from user dissatisfaction to the potential for the user of slip and fall. | accessdata.fda.gov |
| August 10, 2026 | 99710 | Class II | Ongoing | Presource Convenience Kits: 1) KIT, PRE OP, Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN, Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE, Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES, Catalog Number: IVS3 | The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in no patient harm or may lead to localized skin or soft tissue infection. Less commonly, systemic infection or other infectious complications may occur. | accessdata.fda.gov |
| July 29, 2026 | 99553 | Class II | Ongoing | Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH, Catalog Number: PBOCGLN17 | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is used on a patient, localized skin effects may occur. These may include irritation, erythema, or mild inflammation. | accessdata.fda.gov |
| July 14, 2026 | 99380 | Class II | Ongoing | Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT, Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD, Catalog Number: 21-4720C; 3) KIT,BOSC MICROLARYNGOSCOPY, Catalog Number: PECGMLBOB; 4) KIT,ASLMC NASAL PACK, Catalog | Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products. | accessdata.fda.gov |
| February 27, 2026 | 98534 | Class II | Ongoing | Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777 | The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes. | accessdata.fda.gov |
| December 26, 2025 | 98228 | Class II | Ongoing | Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, | The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay | accessdata.fda.gov |
| November 12, 2025 | 97976 | Class II | Ongoing | ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus Full Coverage Gown, Closed Back, Regular/Medium, Medium Blue, Non-sterile; | Affected gowns have the incorrect expiration date on the product packaging. Product has a shelf-life of three years which is mislabeled on the product packaging as five (5) years. | accessdata.fda.gov |
| September 18, 2025 | 97539 | Class II | Ongoing | Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SALEM SUMP" PVC TUBE 12FR 48IN 8888264945E ENFit" SALEM SUMP" PVC TUBE 14FR 48IN 8888264960E ENFit" Sa | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214. | accessdata.fda.gov |
| May 13, 2025 | 96849 | Class II | Completed | SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Controller | Incorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. | accessdata.fda.gov |
| May 2, 2025 | 96783 | Class II | Ongoing | Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs | Packaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. | accessdata.fda.gov |
| November 8, 2024 | 95947 | Class II | Ongoing | Cardinal Health Presource Kits: 1) KIT,DIEP FLAP, Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP, Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP, Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP, Catalog Number:PB23DFCM6; 5) KIT,DIEP | Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits. | accessdata.fda.gov |
| November 8, 2024 | 95722 | Class II | Ongoing | Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWH | Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits. | accessdata.fda.gov |
| November 1, 2024 | 95727 | Class II | Ongoing | Convertor Isolation Gown, AAMI Level 3 protection, Product Codes AT6100, AT6100-XL, AT6200, and AT6200-XL | Isolation Gowns were manufactured with raw materials that may fail the hydrostatic pressure specification and therefore would not comply with AAMI (The Association for the Advancement of Medical Instrumentation) Level 3 protection requirements. | accessdata.fda.gov |
| September 25, 2024 | 95487 | Class I | Ongoing | Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777 | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector. | accessdata.fda.gov |
| July 24, 2024 | 95214 | Class II | Ongoing | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 12 Fr/Ch (4.0 mm) x 48 in. (122 cm), Model #8888264929, Sterile; (b) CardinalHealth Salem Sump Dual Lumen Stomach Tube, 14 Fr/Ch (4.7 mm) x 48 in. (122 cm), Model #8 | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a result, changes to labeling were made. | accessdata.fda.gov |
| May 29, 2024 | 94763 | Class II | Ongoing | Presource kits and trays, labeled as: 1) ANGIOGRAPHY PACK, Catalog Number SAN13BS605; 2) ANGIOGRAPHY PACK, Catalog Number SAN13BS606; 3) ANGIOGRAPHY PACK, Catalog Number SAN13BS607; 4) ANGIOGRAPHY PACK, Catalog Number SA | Cardinal Health is following the FDA's recommendations regarding the disposition of affected Jiangsu Shenli Medical Production Co. Ltd (Shenli) Syringes in the Merit Medical supplied finished kits. Merit Medical supplied finished kits are included as components in Presource kits. According to the FDA s communication, these Shenli syringes, located inside a M | accessdata.fda.gov |
| April 17, 2024 | 94407 | Class II | Ongoing | CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic. | Potential contamination of the product with latex adhesive residual. | accessdata.fda.gov |
| March 27, 2024 | 94309 | Class II | Ongoing | Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | accessdata.fda.gov |
| December 28, 2023 | 93676 | Class I | Ongoing | Cardinal Health Monoject, 6ML Enteral Syringe (purple) Low Dose (LDT) - For Use with ENFit Connection System, REF 406SE | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps. | accessdata.fda.gov |
| December 21, 2023 | 93628 | Class II | Terminated | CardinalHealth Suction Canister Liner, MEDI-VAC CRD, REF 65651-510 | The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister. | accessdata.fda.gov |
| December 4, 2023 | 93551 | Class I | Completed | Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline 18 Fr/Ch (6.0mm); Argyle" Suction Catheter Tray with Chimney Valve Sterile Saline, 6 Fr/Ch (2.0 mm); Argyle" Graduated Suction Catheter Tray with Chimney Va | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. | accessdata.fda.gov |
| September 20, 2023 | 93075 | Class I | Ongoing | Monoject 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack | Demonstrated recognition and compatibility issues with syringe infusion pumps. | accessdata.fda.gov |
| September 13, 2023 | 93019 | Class II | Ongoing | Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777 | Syringe contains conical tip that is not compatible with certain needleless IV connector(s). | accessdata.fda.gov |
| August 16, 2023 | 92875 | Class II | Ongoing | Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa. | Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). | accessdata.fda.gov |
| June 16, 2023 | 92529 | Class II | Ongoing | NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 | Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape. | accessdata.fda.gov |
| April 6, 2023 | 92283 | Class II | Ongoing | Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery | Inadvertently released for distibution without sterility assurance. | accessdata.fda.gov |
| December 14, 2022 | 91322 | Class II | Ongoing | Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186 | Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips. | accessdata.fda.gov |
| November 18, 2022 | 91560 | Class II | Ongoing | Cardinal Health Presource Packs IV START KIT- Intended for IV access device CATALOG #: 01-5798B | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there is a gap between the connectors top and bottom housings which may lead to fluid leaks and loss of fluid path integrity | accessdata.fda.gov |
| September 28, 2022 | 90955 | Class II | Ongoing | Cardinal Health GEL PACK REUSABLE, EXTRA SMALL, Cat. 61115 | Users are being informed that the product should not be used on infants/neonates. A caution statement will be added to the labeling stating: Not for use on Infants/Neonates. | accessdata.fda.gov |
| March 15, 2022 | 89832 | Class II | Completed | Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves | Product was distributed without being sterilized. | accessdata.fda.gov |
| May 21, 2021 | 88046 | Class II | Terminated | Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations. | accessdata.fda.gov |
| February 25, 2021 | 87431 | Class II | Terminated | In-View Clear Leggings Sterile | Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick, which may prevent the products from being unfolded and applied properly. | accessdata.fda.gov |
| February 11, 2021 | 87343 | Class II | Terminated | JUDKINS PACK | Component Part Number: 19537LBL (LBL, SHEET OF 39, ASSORTED, STDSZ, MULTI W/BLK INK, WATERPROOF) is being reported as intermittently mixed with an incorrect medication label sheet throughout the specific Presource kit SANHDJTVCF Judkins Pack lot # 525067. | accessdata.fda.gov |
| January 19, 2021 | 87281 | Class II | Completed | Enteral Infusion Pump | The potential for air appearing in the enteral feed pumping set tubing during set-up. | accessdata.fda.gov |
| January 7, 2021 | 87145 | Class II | Terminated | Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K | Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns. | accessdata.fda.gov |
| January 7, 2021 | 87134 | Class II | Ongoing | Gown Isolation W/Ties Univ Ylw, SKU 1100PG, V1100PG, 2100PG, V2100PG, 2150PG, V2100PG Cardinal Health Isolation Gown, Lab Coat, and Kendall" Gowns are intended to provide minimal barrier protection to protect health care | There is a potential for rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns and lab coats. | accessdata.fda.gov |
| July 29, 2020 | 86131 | Class II | Completed | PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. | accessdata.fda.gov |
| June 4, 2020 | 85803 | Class II | Terminated | Cardinal Health NPWT Canister with Gel 300cc, Prescription Only - Product Usage: The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. | accessdata.fda.gov |
| January 31, 2020 | 84835 | Class II | Terminated | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020 | The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. | accessdata.fda.gov |
| January 31, 2020 | 84834 | Class II | Terminated | Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included. | The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. | accessdata.fda.gov |
| October 31, 2018 | 81579 | Class II | Terminated | Protexis Neoprene Surgical Glove, Size 5.5 This powder-free sterile light brown colored surgeons gloves are a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgic | Labeling issue in that the breakthrough (i.e., permeation) times for two chemotherapy drugs (Carmustine and Thiotepa) stated on the wallet (primary packaging) of the Protexis Neoprene surgical gloves are incorrect. Additionally, breakthrough times for Mitomycin were added to the same label in error. | accessdata.fda.gov |
| June 11, 2018 | 80288 | Class II | Terminated | Hydroline Trumpet Valve with Pulse Wave Cassette, Cassette Trumpet Valve with Bariatric Probe, Double Spike, Ref ABP1201, packaged 1/box, 12 boxes/case, single use, RX, Sterile. | The suction valve may not close properly which could cause continuous suction. | accessdata.fda.gov |
| March 28, 2018 | 79702 | Class II | Terminated | Medi-Vac(TM) Flex Advantage(TM) Suction Canister Liner, Material Numbers: a) REF 6561-910C b) REF 6561-916K c) REF 6561-920C To remove blood and/or body fluids. These fluids may be suctioned during surgical procedures or | products may be missing a one-way valve on the fluid patient port. | accessdata.fda.gov |
| February 20, 2018 | 80289 | Class II | Terminated | Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit. | accessdata.fda.gov |
| August 1, 2017 | 77895 | Class II | Terminated | Presource(R) Kits (custom surgical/procedural kits): The standard and custom kits are packed with all of the specific disposable class I, II, and II implantable, life-supporting, or life-sustaining devices required by cu | The firm manufactured and distributed Presource(R) kits which contained BD SafetyGlide" 22GA 1 inch Needles. BD subsequently recalled these needles because, " Loose polypropylene particulate in the fluid path could be expelled out of the needle during injection. | accessdata.fda.gov |
| July 28, 2017 | 77917 | Class II | Terminated | Convertors Robotic Drape with Attached Leggings; Product is packaged as Single Sterile Drape/8 per Case | Product 29474 LAVH drape was packaged as 29574 Robotic Drape with Leggings. | accessdata.fda.gov |
| June 27, 2017 | 77686 | Class II | Terminated | Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intende | Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside. | accessdata.fda.gov |
| April 21, 2017 | 77127 | Class II | Terminated | Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound dr | Product's seal possibly compromised, potentially compromising the sterility of the package contents. Use of impacted products could result in an increased risk of infection. | accessdata.fda.gov |
| July 20, 2016 | 75019 | Class II | Terminated | BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transf | Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design specifications, specifically 16 CFR 1611 - Standard for the Flammability of Vinyl Plastic Film. The standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. The method requires that the test be perf | accessdata.fda.gov |
| June 27, 2016 | 74706 | Class II | Terminated | The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Metabolite Analysis. | Arterial Blood Gas (ABG) Kit- Missing Safety Component. The ABG Kit(s) have been identified as missing the locking clasp component. CareFusion/BD has identified a potential customer/user safety risk associated with the missing locking clasp component. | accessdata.fda.gov |
| February 29, 2016 | 73497 | Class II | Terminated | Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of a male infant. | Two lots of Gomco Style Circumcision Clamp Trays, SSI-0034 and 10-1100 contained a 1.3cm circumcision clamp. They both were labelled as containing a 1.1cm clamp. | accessdata.fda.gov |
| August 25, 2015 | 72078 | Class II | Terminated | Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants | Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20. | accessdata.fda.gov |
| December 23, 2014 | 70185 | Class II | Terminated | Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is used in surgical or medical emergency facilities. Primarily used on infants and pediatric patients. | A small piece of the stylet sheath has the potential to shear off upon removal of the stylet from the tracheal tube. | accessdata.fda.gov |
| March 26, 2013 | 64736 | Class I | Terminated | Presource PBDS, Gyn Laparoscopy Kit, Circulator | Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow. | accessdata.fda.gov |
| December 18, 2012 | 63951 | Class II | Terminated | Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat. No. 3FA40SSA) Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbere | Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility. | accessdata.fda.gov |
| January 27, 2012 | 61048 | Not yet classified | Terminated | Presource Custom Sterile Surgical and Procedure Kits containing Ethicon Ethilon Black Nylon Nonabsorbable Surgical Sutures in new Tyvek packaging; surgical trays; Cardinal Health. The kits are custom packed with all of t | The Presource kits were assembled with Ethicon Sutures in new Tyvek packaging which could no longer be placed in kits that will undergo ethylene oxide sterilization. | accessdata.fda.gov |
| December 23, 2011 | 60845 | Not yet classified | Terminated | Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the followin | The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance. | accessdata.fda.gov |
| December 12, 2011 | 60823 | Not yet classified | Terminated | Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the followin | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product. | accessdata.fda.gov |
| September 30, 2011 | 60069 | Not yet classified | Terminated | Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the followin | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturers do not have all necessary FDA registrations or filings needed for these components. | accessdata.fda.gov |
| September 3, 2011 | 59909 | Not yet classified | Terminated | Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; Cardinal Health, McGaw Park, IL 60085; The kit catalog numbers listed in the code information section below contain one or more of the followin | Some of the components contained in the Presource kits are being recalled because Cardinal Health has determined that the component manufacturer(s) does not have all necessary FDA registrations or filings needed for this product. | accessdata.fda.gov |
| February 28, 2011 | 58054 | Not yet classified | Terminated | Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; T | The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly. | accessdata.fda.gov |
| January 28, 2011 | 57880 | Not yet classified | Terminated | Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esm | Esmark bandages placed in some Presource kits/modules may not have been adequately sterilized. | accessdata.fda.gov |
| August 16, 2010 | 56563 | Not yet classified | Terminated | Medi-Vac Non-Conductive Suction Tube with Maxi-Grip Connectors, Inner Diameter: 5 mm (3/16"), Length: 1.8 m (6 ft.); Sterile, for single use only, 50 tubes per case; Cardinal Health, McGaw Park, IL 60085 USA, Made in Mex | The packaging seals may not be intact, resulting in compromised sterility for the listed Medi-Vac Non-Conductive Tubing. | accessdata.fda.gov |
| April 1, 2010 | 55215 | Not yet classified | Terminated | Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH | The sterility of the staplers is questionable. | accessdata.fda.gov |
| August 28, 2009 | 53137 | Not yet classified | Terminated | Cardinal Health, Craig Calibrated Cannula, overall length 5-3/8" (13.7 cm), catalog #OS5000-005, sold separately, or as a component of the Craig Vertebral Biopsy Set, catalog #OS5000 | The Craig Calibrated Cannula does not interface with the toothed cutter properly, which may prevent the toothed cutter from properly advancing through the cannula to the biopsy site. | accessdata.fda.gov |
| April 24, 2009 | 52027 | Not yet classified | Terminated | Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene surgical glove, latex-free, used as an underglove when double-gloving; 1 pair of gloves per sterile pouch, 200 pairs per | Increase in the number of customer complaints due to cuff tears. | accessdata.fda.gov |
| November 18, 2008 | 50198 | Not yet classified | Terminated | Esmark Elastic Bandage, 3" x 4 yards, sterile, for single use only, latex free. Distributed by Cardinal Health, McGaw Park, IL 60085-6787. The device is used to promote blood flow from the extremities by compressing the | The natural rubber latex bandages were mislabeled as latex free. | accessdata.fda.gov |
| June 25, 2008 | 48726 | Not yet classified | Terminated | Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually pac | The male Luer adapter may be the wrong component therefore the feeding set would not be able to be connected to the tube nor would the cap fit securely. | accessdata.fda.gov |
| February 12, 2008 | 46795 | Not yet classified | Terminated | Presource Standard Sterile OR Scissors; straight scissors, S/B, 5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a tyvek top, 50 units per case; Cardinal Health, McGaw Park, IL 60085; catalo | The product has the potential of being non-sterile. | accessdata.fda.gov |
| January 4, 2008 | 46294 | Not yet classified | Terminated | AirLife Infant nCPAP System Driver (Catalog No: 006900;) a nasal continuous positive airway pressure device, which is part of a larger system that includes an Infant Nasal CPAP generator, fixation device and patient inte | Oxygen fluctuations - The AirLife Infant Nasal CPAP System exhibited O2 fluctuations when used with low O2 flow rates when the PTO/Auxillary port on the driver is used as a blender in administering O2 therapy via nasal cannula at flow rates of less than 4L/min. | accessdata.fda.gov |
| June 1, 2007 | 38062 | Not yet classified | Terminated | AirLife nCPAP System Driver; a nasal continuous positive airway pressure device, which is part of a larger system that includes an nCPAP generator, fixation device and patient interface (prongs and.or mask); Cardinal Hea | Under isolated conditions, the device may experience issues with O2 Calibration, which may result in either a nuisance alarm or a delivered FiO2 of up to 5% below the specified tolerance. | accessdata.fda.gov |
| September 27, 2006 | 36421 | Not yet classified | Terminated | Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the following configurations: a) | The cardiovascular drape may tear and/or fray at the reinforced fenestrated trough area during use. | accessdata.fda.gov |
| October 3, 2005 | 33767 | Not yet classified | Terminated | Cardinal Health Custom Sterile Latex Free Convenience Kits; sterile single use disposable devices packaged in plastic pouches; Cardinal Health, McGaw Park, IL 60085 U.S.A.; identified by the following catalog numbers: a) | The procedure kits labeled as latex-free may contain a 4' or 6' ultra-weave premium elastic bandage containing dry, natural rubber latex. | accessdata.fda.gov |
| October 27, 2004 | 30330 | Not yet classified | Terminated | V. Mueller Pfister-Schwartz Stone Retriever 4-Wire Basket, Without Filiform Tip; a sterile, single use kidney stone retriever device; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA | The dispenser box was mislabeled with the wrong length and the wrong wire gauge. | accessdata.fda.gov |
| July 28, 2004 | 29739 | Not yet classified | Terminated | Jackson-Pratt Hemaduct, 15 Fr round, full duct silicone wound drain; a sterile, single use only, Rx device, individually packaged, 10 drains per box, 8 boxes per case; catalog #JP-HUR880; Allegiance Healthcare Corporatio | The products labeled as sterile are not sterile. | accessdata.fda.gov |
| November 15, 2003 | 27757 | Not yet classified | Terminated | Custom Sterile Cardiac Cath Pack, catalog SAN25CCEAQ, Cardinal Health, McGaw Park, IL 60085 USA | The Namic Angiography Kit attached to the outside top of the Custom Sterile Pack is not sterile. | accessdata.fda.gov |
| November 3, 2003 | 27654 | Not yet classified | Terminated | Prolene Polyproplyene Mesh, 3'' x 6'', Nonabsorbable Synthetic Surgical Mesh; six packages per box; sterile; product code PMII; Ethicon Inc., Somerville, NJ 08876 | Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII. | accessdata.fda.gov |
| June 27, 2003 | 26609 | Not yet classified | Terminated | Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see code information for details. The product packaging consists of a vented polybag with a label insert inside the po | The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized. | accessdata.fda.gov |
| June 2, 2003 | 26426 | Not yet classified | Terminated | Temno Chiba FIne Needle Aspiration, Soft Tissue Biopsy Needle, 18 GA x 15 cm., product CHI1815, Allegiance, a Cardinal Health Company, McGaw Park, IL 60085 USA, Made in Dominican Republic | The product was shipped prior to being sterilized. | accessdata.fda.gov |
| January 22, 2003 | 25475 | Not yet classified | Terminated | Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; individually packaged drapes, 20 packages per case | The product labeled as sterile had not been through its sterilzation cycle. | accessdata.fda.gov |
| November 15, 2002 | 25054 | Not yet classified | Terminated | Pharmaseal Thoracentesis Tray with Catheter, catalog number 4341B; a sterile, single use, Rx, latex free procedure tray containing a 7'' long Thoracentesis Catheter with a 14 gauge x 2'' needle, catheter guard, 60 ml syr | Raw material used in the manufacture of catheters may contain a contaminant predisposing the catheter to become brittle, possibly breaking during use. | accessdata.fda.gov |
Compare with other makers
- All makers of Oximeter
- All makers of Container, Liquid Medication, Graduated
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Accessories, Catheter, G-U
- All makers of Scissors, Wire Cutting, Ent, Sterile
Updated October 2, 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.