Data / Medical devices / United States / Bayer Medical Care Inc.
Bayer Medical Care Inc.: FDA-registered device maker in Indianola, PA, United States, 45 510(k) clearances
Bayer Medical Care Inc. is registered with the FDA (registration 2520313) in Indianola, PA, United States. It lists 15 device types. The FDA files 45 510(k) clearances under its listings, the newest dated February 13, 2026. 29 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2520313
- Address
- 1 Bayer Drive, Indianola, PA, United States, 15051
- Owner or operator
- Bayer Medical Care Inc. (2520313)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- August 20, 1992
- Registered through
- 2026
- Brand names listed
- 50 cm Low Pressure Connector Tube, Burnett TMJ Appliance, CT TRI-PAK Sterile Disposable Syringe Kit, Connect.CT, Continuum MR Infusion System with Wireless Remote, Continuum Microbore Administration Sets, Continuum Primary MR Administration Kit, Continuum Secondary MR Administration Kit and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cephalometer | EAG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Injector And Syringe, Angiographic | DXT | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Injector, Contrast Medium, Automatic | IZQ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Iodinated Contrast Media Transfer Tubing Set | PQH | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Pump, Infusion | FRN | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. | DOY | 2 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Set, I.V. Fluid Transfer | LHI | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Manufacturer | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tubing, Fluid Delivery | FPK | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Tubing, Pump, Cardiopulmonary Bypass | DWE | 2 | Complaint file establishment | 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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2026 | K252891 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2) | DXT | Substantially Equivalent | Bayer Medical Care, Inc. | accessdata.fda.gov |
| November 5, 2024 | K241849 | MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2) | IZQ | Substantially Equivalent | Imaxeon Pty, Ltd. | accessdata.fda.gov |
| July 30, 2020 | K200280 | MEDRAD Imaging Bulk Package Transfer Spike | PQH | Substantially Equivalent | Bayer Medical Care, Inc. | accessdata.fda.gov |
| November 1, 2018 | K182276 | MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit | DXT | Substantially Equivalent | Bayer Medical Care, Inc. | accessdata.fda.gov |
| November 1, 2018 | K182273 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | Substantially Equivalent | Bayer Medical Care, Inc. | accessdata.fda.gov |
| August 17, 2018 | K173773 | MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT | DXT | Substantially Equivalent | Bayer Medical Care, Inc. | accessdata.fda.gov |
| May 4, 2018 | K173913 | MEDRAD® Imaging Bulk Package Transfer Set | PQH | Substantially Equivalent | Bayer U.S., LLC | accessdata.fda.gov |
| August 14, 2015 | K143538 | MRXperion MR Injection System, MRXperion MR Injection System Syringe Kit | DXT | Substantially Equivalent | Bayer Medical Care, Inc. | accessdata.fda.gov |
| January 23, 2014 | K132928 | MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE | DXT | Substantially Equivalent | Medrad, Inc. / Bayer Medical Care, Inc. | accessdata.fda.gov |
| August 2, 2013 | K131517 | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | FPK | Substantially Equivalent | Medrad, Inc. / Bayer Medical Care, Inc. | accessdata.fda.gov |
| December 15, 2011 | K113133 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| October 14, 2011 | K112086 | MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 23, 2010 | K100798 | MEDRAD INTEGO PET INFUSION SYSTEM, SOURCE ADMINISTRATION SET, PATIENT ADMINSTRATIN SET MODEL INT SYS 100, INT CSS, INT C | FRN | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 5, 2009 | K083723 | A6 LUER ACCESS DEVICE | FPA | Substantially Equivalent | B.Braun Medical, Inc. | accessdata.fda.gov |
| January 12, 2009 | K082905 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| October 17, 2008 | K082458 | P3T ABDOMEN | JAK | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 17, 2008 | K080297 | MEDRAD INTEGO PET INFUSION SYSTEM | FRN | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| May 30, 2008 | K073051 | MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY | FRN | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| December 21, 2007 | K072886 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| March 27, 2007 | K063090 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH XDS ACCESSORY | IZQ | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 22, 2005 | K051499 | INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET | FPA | Substantially Equivalent | Medegen Medical Manufacturing Services | accessdata.fda.gov |
| June 17, 2005 | K050456 | MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| December 10, 2004 | K042784 | MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| September 29, 2004 | K042569 | 8600 VITAL SIGNS MONITOR | MWI | Substantially Equivalent | Criticare Systems, Inc. | accessdata.fda.gov |
| March 2, 2004 | K033881 | MEDRAD STELLANT CT INJECTOR SYSTEM WITH IMAGING SYSTEM INTERFACE MODULE | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| August 1, 2003 | K031483 | MEDRAD MANUAL SYRINGE LOADER | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| July 11, 2003 | K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET | FPK | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| January 10, 2003 | K023183 | MEDRAD STELLANT CT INJECTOR SYSTEM | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| September 5, 2002 | K022431 | MEDRAD TRANSFER SET | FPK | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| December 13, 2001 | K013815 | MEDRAD QWIK-FIT SYRINGE | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| October 4, 2001 | K012950 | MODIFICATION TO: MEDRAD SPECTRIS SOLARIS MR INJECTOR SYSTEM | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| July 21, 1999 | K991557 | MEDRAD VISTRON CT INJECTOR SYSTEM | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| March 11, 1999 | K984418 | UNIVERSAL ADJUSTABLE T-RAIL TABLE BRACKET | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| October 9, 1998 | K982814 | MEDRAD VISTRON CT INJECTOR SYSTEM | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| May 4, 1998 | K980417 | MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V | LNH | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| September 25, 1995 | K935668 | MEDRAD SPECTRIS MR INJECTOR | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| June 15, 1995 | K934086 | MEDRAD ENVISION CT INJECTOR AND QWIK FIT SYRINGE | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| November 29, 1994 | K944983 | MEDRAD COUNTERPOISE SYSTEM | JAK | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| January 21, 1993 | K924116 | MEDRAD MCT, MCT PLUS INJECTOR/MEDRAD FRONT LOAD | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| September 26, 1990 | K903390 | MEDRAD MARK V-PLUS INJECTOR | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| February 24, 1987 | K870243 | BURNETT TMJ APPLIANCE | EAG | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| May 9, 1983 | K831188 | CONNECTOR TUBE | DOY | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| September 28, 1982 | K822536 | MARK V | DXT | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| April 17, 1981 | K810924 | MEDRAD HIGH PRESSURE CONECTING TUBE | DWE | Substantially Equivalent | Medrad, Inc. | accessdata.fda.gov |
| April 29, 1980 | K800823 | QUICK FILL | DXT | Substantially Equivalent | Medrad, 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 |
|---|---|---|---|---|---|---|
| July 31, 2026 | 99698 | Class II | Ongoing | MEDRAD Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System; Catalog number: FLEXS-150-QFT | Some devices may not have been properly sterilized due to a manufacturing sterilization issue. | accessdata.fda.gov |
| April 24, 2026 | 98881 | Class II | Ongoing | Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta Injection System; Catalog number: AVA 500 MPAT (Part 2 of 2); Affected material numbers: 87629007, 60729458, 86566648 | Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage | accessdata.fda.gov |
| November 30, 2022 | 91273 | Class II | Ongoing | Source Administration Set (SAS) used with the Medrad Intego PET Infusion System, Sterile Catalog number: INT CSS Affected material number: 86566621 Intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) or 18 | Black specks may be present on the packaged needles | accessdata.fda.gov |
| September 14, 2021 | 88807 | Class II | Terminated | The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syringe made from a clear polycarbonate material and is an accessory to the MEDRAD Mark 7 Arterion Injection System. It is designed to be loaded i | Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR) | accessdata.fda.gov |
| October 5, 2020 | 86619 | Class II | Terminated | Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Syringe Catalog/REF Number: FLEXD-150-SCS Description: 2 - 150 mL FLEX syringes, 1 large saline spike, 1 small contrast spike, patient t-connector t | Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe. | accessdata.fda.gov |
| December 14, 2018 | 81808 | Class II | Terminated | MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis In | If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall. | accessdata.fda.gov |
| September 7, 2018 | 80945 | Class II | Terminated | Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administration Sets (PAS) and Intego PET Infusion Systems Product Usage: 1.2 micron filter for use with Intravenous Administration Sets | Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path. | accessdata.fda.gov |
| June 28, 2018 | 80727 | Class II | Terminated | Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Catalog # OCS 115A, Material Number 59880253 | The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the oper | accessdata.fda.gov |
| November 7, 2016 | 75736 | Class II | Terminated | MEDRAD Intego PET Infusion System - Pump Intended to deliver accurate doses of Fluoredeoxyglucose or F-Sodium Fluoride and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnost | Bayer has determined that all current Source Administration Sets (SAS) used with the Medrad Intego Pet Infusion System may produce particulates in radiopharmaceutical (RP) vials when the needle is inserted. | accessdata.fda.gov |
| September 30, 2016 | 75387 | Class II | Terminated | PET Infusion Pump | The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date. | accessdata.fda.gov |
| August 2, 2016 | 74974 | Class II | Terminated | Certegra Workstation used in conjunction with Medrad Stellant CT Injection System Catalog Number # CWKS DISPLAY Serial Numbers The Medrad Stellant CT Injector System is intended for the specific purpose of injecting intr | CertegraWorkstation when used in conjunction with the Medrad Stellant CT Injection System may exhibit thermal events, such as: smoke and sparks of fire. | accessdata.fda.gov |
| June 9, 2016 | 74513 | Class II | Terminated | Angiographic Injector and Syringe, MEDRAD MRXperion MR Injection System, MEDRAD MRXperion Sterile Disposable MRI Kit Usage: The MEDRAD MRXperion MR Injection System is a syringe based fluid delivery system indicated for | Bayer Healthcare is initiating this recall due to complaints that were received from customer sites describing a 4205 error message when the injector is used with a 3T scanner. | accessdata.fda.gov |
| November 30, 2015 | 72817 | Class II | Terminated | Medrad Source Administration Sets, Catalog number INT CSS. For use with MEDRAD Intego PET Infusion pump Systems, in nuclear medicine diagnostic procedures. | The firm's investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system failing to position the dose correctly during extraction, potentially leading to a low measurement of the extracted dose or to a higher dose being extracted. The occluded SAS tubing may impair the priming f | accessdata.fda.gov |
| August 4, 2015 | 71994 | Class II | Terminated | Angiographic Injector. Medrad Mark 7 Arterion Injection System, which utilizes Software Version SW 005.006_SH; to be used specifically for the purposes of injecting contrast medium and common flushing solutions into huma | Software Version SW 005.006_SH, resulted in the removal of purge enforcement from traditional New-Case, Power Up and Syringe Change use cases while the injector head is in the upright position. | accessdata.fda.gov |
| September 20, 2013 | 71296 | Class II | Terminated | MEDRAD Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications. | The root cause investigation showed that the under-volume hazard can occur when the unit has been configured to prime with contrast, but instead primes with saline due to the configuration data not being sent to the injector head. This may create a non-optimal priming condition that could lead to under-infusion. | accessdata.fda.gov |
| April 15, 2013 | 65411 | Class II | Terminated | DC power cable (p/n 3010556) supplied with the MEDRAD(R) Veris MR Vital Signs Monitor: Product Usage: Monitor, Physiological, Patient | The firm is recalling these power cables due to a latent design reliability issue and the potential for shorting which can result in heating/melting of the cable jacket. | accessdata.fda.gov |
| April 18, 2012 | 61734 | Class II | Terminated | Medrad(R) Continuum MR Infusion Pump Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and | Bayer HealthCare is recalling all MEDRAD(R) Continuum MF Infusion System tubing sets (macrobore and microbore), catalog numbers MIK200A, MIL 200B, 3015153, 3015155, 3015156, 3015157, 3015158, 3015159, and 3015161. The firm is initiating this recall because this tubing exhibits a variation that, when used in conjunction with any Continuum pump, may result in | accessdata.fda.gov |
| October 24, 2011 | 60240 | Not yet classified | Terminated | Medrad(R) Sterile Disposable Stellant Syringe Kit, Catalog # SDS-CTP-SPK, Lot # 112865. Angiographic syringe intended to be used for the specific purpose of injecting intravenous contrast media into humans for diagnostic | Packaging may exhibit open seals - sterility compromised | accessdata.fda.gov |
| June 2, 2011 | 59167 | Not yet classified | Terminated | MEDRAD Avanta Fluid Management Injection System, Catalog numbers: AVA 500 TABL, AVA 500 PEDL Product Usage: Administration of intravascular radio-opaque contrast media and common flushing solutions during angiographic pr | Event was initially intended to be a product enhancement of the MEDRAD Avanta Fluid Management Injection System. Upgrades were initiated in October, 2007. Observance of a possible increase in complaints and adverse event reporting resulted in the firm issuing "Important Product Use Reminder" to remind users of proper procedures for using the system and the n | accessdata.fda.gov |
| January 6, 2010 | 54453 | Not yet classified | Terminated | Avanta Fluid Management Injection System, Avanta Multi-Patient Disposable Set (MPAT) High Pressure Check Valve, Catalog number AVA 500 MPAT, Material number 3018231. | The product may be defective resulting in a reduction of the saline delivery rate and inadequate air purging. | accessdata.fda.gov |
| January 29, 2009 | 51495 | Not yet classified | Terminated | MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media. | Possible compromised sterility due to holes in styrene tray | accessdata.fda.gov |
| October 25, 2007 | 45817 | Not yet classified | Terminated | Medrad Avanta Multi-Patient Disposable Hand Controller, Angiographic Injector and Syringe. Catalog number AVA 500 HC, For Use with MEDRAD Avant Fluid Management System, MEDRAD, Inc., Indianola, PA 15051 | Sterility (package integrity) compromised: Incomplete package seal; sterility may be compromised | accessdata.fda.gov |
| September 29, 2006 | 36596 | Not yet classified | Terminated | Invasive Blood Pressure Interface Cables: a) Medrad 9500 Multigas monitor for MRI, Invasive Blood Pressure Interface Cable (Part # 3006314) for use with Abbott/Hospira IBP Transducer b) Invasive Blood Pressure Interface | Interference problems: certain invasive blood pressure transducers connected to these cables are susceptible to interference if exposed to static magnetic field strengths exceeding 300 gauss. In certain orientations, the transducer causes the invasive blood pressure readings on the physiological monitor to display inaccurate readings. | accessdata.fda.gov |
| October 10, 2005 | 33846 | Not yet classified | Terminated | Stellant CT Injection System. Powered Injector with Syringe. Angiographic Injector and Syringe. Model numbers S, SX, D, and DX | the heat maintainer, an accessory, may overheat and deform the disposable syringe | accessdata.fda.gov |
| October 7, 2005 | 33816 | Not yet classified | Terminated | Medrad Overhead Counterpoise System II. Support Arm. Mount Injector Head. Catalog numbers 3010544, 3010545, 3010546, 3010547, 3010548, 3010549, 3010550, 3010551, 3010552, and 3010553. | overhead system can fall due to the failure of a retaining ring. | accessdata.fda.gov |
| September 20, 2005 | 33689 | Not yet classified | Terminated | Medrad Avanta Single Patient Disposable Sets. Catalog number AVA 500 SPAT | stress crack on the stopcock | accessdata.fda.gov |
| March 22, 2005 | 31565 | Not yet classified | Terminated | Continuum MR Compatible Infusion Pump. Pump Model #3009135 | Customer complaint that a continuum infusion pump was attracted to an MR scanner due to customer not completely engaging the pump into the bracket. | accessdata.fda.gov |
| November 3, 2004 | 30432 | Not yet classified | Terminated | Stellant Dual Syringe Kits. CT Injector and Accessories. Catalog Number SDS-CTP-QFT and SDS-CTP-SPK. | Sterility can be compromised by a tear in the outer packaging. | accessdata.fda.gov |
| October 8, 2004 | 30240 | Not yet classified | Terminated | Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT | Sterility can be compromised by a component tearing the outer packaging | accessdata.fda.gov |
Compare with other makers
- All makers of Injector And Syringe, Angiographic
- All makers of Pump, Infusion
- All makers of Tubing, Fluid Delivery
- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of Set, Administration, Intravascular
- All makers of Tubing, Pump, Cardiopulmonary Bypass
Updated September 11, 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.