Baxter Healthcare Corp.
Deerfield, IL, United States
This page shows every FDA and USDA recall linked to Baxter Healthcare Corp.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
93
Total Recalls
2009
First Recall
2016
Most Recent
12
Class I (Most Serious)
Drug: 33
Device: 60
Class II: 21
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634
Product Usage:
The Revacl...
Nov 8, 2016
· Device
Terminated
V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LL...
Sep 28, 2016
· Device
Terminated
sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 3570...
Sep 28, 2016
· Device
Terminated
Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BA...
Sep 28, 2016
· Device
Terminated
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes:
1 cm x 6 cm, product...
Aug 12, 2016
· Device
Terminated
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Jun 24, 2016
· Device
Terminated
Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusi...
Jun 15, 2016
· Drug
Class I
Terminated
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Ba...
Jun 1, 2016
· Drug
Class I
Terminated
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL...
May 18, 2016
· Drug
Class II
Terminated
GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC
Product Usage:
The FlowCO...
Apr 21, 2016
· Device
Terminated
GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC
Product Usage:
The FlowCOU...
Apr 21, 2016
· Device
Terminated
GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC
Product Usage:
The FlowCO...
Apr 21, 2016
· Device
Terminated
GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC
Product Usage:
The FlowCO...
Apr 21, 2016
· Device
Terminated
GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC.
Product Usage:
The FlowC...
Apr 21, 2016
· Device
Terminated
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 600...
Mar 9, 2016
· Drug
Class II
Terminated
Automated peritoneal dialysis (APD) cycler
Feb 16, 2016
· Device
Terminated
Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687,
Product Usag...
Nov 30, 2015
· Device
Terminated
Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433,
Product Usage:
C8433: For the administration of fluids from...
Nov 30, 2015
· Device
Terminated
Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s,...
Nov 30, 2015
· Device
Terminated
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) ther...
Nov 17, 2015
· Device
Terminated
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACE...
Oct 16, 2015
· Device
Terminated
Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
Oct 6, 2015
· Device
Terminated
MiniCap Extended Life PD Transfer Set. Product Code 5C4449.
intended for use with Baxter Locking titanium ad...
Aug 27, 2015
· Device
Terminated
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160.
intended for use with containers o...
Aug 27, 2015
· Device
Terminated
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483.
intended for...
Aug 27, 2015
· Device
Terminated
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482.
intended for use with Bax...
Aug 27, 2015
· Device
Terminated
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only...
Aug 26, 2015
· Drug
Class I
Terminated
0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxter Healthcare Corporation Deerfie...
Aug 19, 2015
· Drug
Class II
Terminated
10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pit...
Jul 15, 2015
· Drug
Class I
Terminated
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container,...
Jun 17, 2015
· Drug
Class II
Terminated
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the c...
Apr 27, 2015
· Device
Terminated
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion Syst...
Apr 16, 2015
· Device
Terminated
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, De...
Apr 15, 2015
· Drug
Class I
Terminated
Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL...
Apr 8, 2015
· Drug
Class II
Terminated
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Co...
Apr 1, 2015
· Drug
Class II
Terminated
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.
Mar 13, 2015
· Device
Completed
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients...
Mar 4, 2015
· Device
Terminated
Fluconazole Injection, USP, 200 mg/100 mL (2 mg/mL), 100 mL Single-Dose INTRAVIA Container bag, packaged in 10...
Feb 4, 2015
· Drug
Class II
Terminated
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path.
Product Usage: The recal...
Feb 2, 2015
· Device
Terminated
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310,...
Jan 29, 2015
· Device
Terminated
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC
Plastic Containers, Approximate Lengt...
Jan 26, 2015
· Device
Terminated
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's
HomeChoice and HomeChoice Pro...
Jan 7, 2015
· Device
Terminated
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automate...
Jan 7, 2015
· Device
Terminated
Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections,...
Dec 24, 2014
· Drug
Class II
Terminated
Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G3424, Sterile Nonpyrogenic, 50 mL Is...
Dec 17, 2014
· Drug
Class II
Terminated
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container,...
Dec 3, 2014
· Drug
Class II
Terminated
Potassium Chloride Injection, 10mEq per 100mL, 100 mL Sterile single dose container bags, Rx only, Baxter USA,...
Dec 3, 2014
· Drug
Class II
Terminated
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixtur...
Oct 31, 2014
· Device
Terminated
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Ac...
Oct 31, 2014
· Device
Terminated
15 L Cycler Drainage Bag
Product Usage:
For use with Baxter Cycler Tubing sets as a peritoneal dialysis acce...
Oct 17, 2014
· Device
Terminated