Baxter Healthcare Corp.

FDA Regulatory Profile

Summary

Total Recalls
144 (35 Class I)
510(k) Clearances
508
Inspections
11
Compliance Actions
0

Known Names

baxter healthcare, baxter healthcare corporation

Recent Recalls

NumberClassProductDate
Z-3133-2017Class IIBaxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479September 1, 2017
Z-0370-2017Class IIGAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product UsagOctober 12, 2016
Z-0671-2017Class IIBaxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product CoSeptember 28, 2016
Z-0672-2017Class IIV6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -September 28, 2016
Z-0670-2017Class IIsigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, ProductSeptember 28, 2016
Z-2533-2016Class IISynovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cJune 24, 2016
Z-2049-2016Class IIPrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement TherapyMay 23, 2016
Z-1840-2016Class IICOSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achMay 12, 2016
Z-1839-2016Class IICOSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achMay 12, 2016
Z-1838-2016Class IICOSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achiMay 12, 2016
Z-1628-2016Class IIGEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product UsagApril 21, 2016
Z-1629-2016Class IIGEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product UsageApril 21, 2016
Z-1627-2016Class IIGEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product UsageApril 21, 2016
Z-1631-2016Class IIGEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product UsageApril 21, 2016
Z-1630-2016Class IIGEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: April 21, 2016
D-0852-2016Class IIBrevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mLApril 12, 2016
Z-1565-2016Class IIAutomated peritoneal dialysis (APD) cyclerFebruary 16, 2016
D-0731-201Class II0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, DeerfieFebruary 5, 2016
D-0861-2016Class II0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container baJanuary 21, 2016
D-0862-2016Class I0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container baJanuary 21, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD TranMarch 12, 2024
K192705MiniCap Extended Life PD Transfer SetsOctober 25, 2019
K190910PrisMax System Version 2July 25, 2019
K163530PrisMax Control UnitMay 3, 2017
K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TOctober 29, 2015
K130531ULTRAFUSEApril 8, 2014
K132734NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETSOctober 8, 2013
K130245LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE March 1, 2013
K123874INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLIJanuary 10, 2013
K123868INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTJanuary 8, 2013
K121092FLOWEASE [SUBCUTANEOUS] INFUSION SETJune 29, 2012
K113227NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTERDecember 8, 2011
K111217ADDITIVE CAPJune 14, 2011
K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310,March 30, 2011
K103551INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXMarch 25, 2011
K103245CELSTATMarch 23, 2011
K101385DUAL LUER LOCK CAP, MODEL 2C6250June 22, 2010
K090002ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002AAugust 7, 2009
K081717TRICOS A RESORBABLE BONE SUBSTITUTEOctober 10, 2008
K081721TRICOS A RESORBABLE SUBSTITUTEAugust 6, 2008