Baxter Healthcare Corp
Baxter Healthcare Corp appears in FDA public data with 144 recalls — including 35 Class I (most serious) —, 508 510(k) clearances, 12 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3133-2017, Class II) was initiated on Sep 1, 2017. Its most recent 510(k) clearance was granted on Mar 12, 2024.
Summary
- Total Recalls
- 144 (35 Class I)
- 510(k) Clearances
- 508
- Inspections
- 12
- Compliance Actions
- 0
Known Names
Baxter Healthcare, Baxter Healthcare Corporation, Baxter Healthcare Anesthesia And Critical Care, Baxter Healthcare Corp./Fenwal
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-3133-2017 | Class II | Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479 | Sep 1, 2017 |
| Z-0370-2017 | Class II | GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usag | Oct 12, 2016 |
| Z-0671-2017 | Class II | Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Co | Sep 28, 2016 |
| Z-0670-2017 | Class II | sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product | Sep 28, 2016 |
| Z-0672-2017 | Class II | V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump - | Sep 28, 2016 |
| Z-2533-2016 | Class II | Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 c | Jun 24, 2016 |
| Z-2049-2016 | Class II | PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy | May 23, 2016 |
| Z-1839-2016 | Class II | COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to ach | May 12, 2016 |
| Z-1838-2016 | Class II | COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achi | May 12, 2016 |
| Z-1840-2016 | Class II | COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to ach | May 12, 2016 |
| Z-1627-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage | Apr 21, 2016 |
| Z-1629-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage | Apr 21, 2016 |
| Z-1630-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: | Apr 21, 2016 |
| Z-1628-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usag | Apr 21, 2016 |
| Z-1631-2016 | Class II | GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage | Apr 21, 2016 |
| D-0852-2016 | Class II | Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL | Apr 12, 2016 |
| Z-1565-2016 | Class II | Automated peritoneal dialysis (APD) cycler | Feb 16, 2016 |
| D-0731-201 | Class II | 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfie | Feb 5, 2016 |
| D-0861-2016 | Class II | 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container ba | Jan 21, 2016 |
| D-0863-2016 | Class I | Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, R | Jan 21, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Tran | Mar 12, 2024 |
| K192705 | MiniCap Extended Life PD Transfer Sets | Oct 25, 2019 |
| K190910 | PrisMax System Version 2 | Jul 25, 2019 |
| K163530 | PrisMax Control Unit | May 3, 2017 |
| K152675 | EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR T | Oct 29, 2015 |
| K130531 | ULTRAFUSE | Apr 8, 2014 |
| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS | Oct 8, 2013 |
| K130245 | LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE | Mar 1, 2013 |
| K123874 | INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLI | Jan 10, 2013 |
| K123868 | INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONT | Jan 8, 2013 |
| K121092 | FLOWEASE [SUBCUTANEOUS] INFUSION SET | Jun 29, 2012 |
| K113227 | NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER | Dec 8, 2011 |
| K111217 | ADDITIVE CAP | Jun 14, 2011 |
| K102936 | HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, | Mar 30, 2011 |
| K103551 | INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EX | Mar 25, 2011 |
| K103245 | CELSTAT | Mar 23, 2011 |
| K101385 | DUAL LUER LOCK CAP, MODEL 2C6250 | Jun 22, 2010 |
| K090002 | ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A | Aug 7, 2009 |
| K081717 | TRICOS A RESORBABLE BONE SUBSTITUTE | Oct 10, 2008 |
| K081721 | TRICOS A RESORBABLE SUBSTITUTE | Aug 6, 2008 |