Baxter Healthcare Corp. recalls

60 recalls on record · latest: September 1, 2017

Official U.S. recall history for Baxter Healthcare Corp., compiled from official government records.

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Baxter Healthcare Corp recalls Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479

September 1, 2017 · Medical device recalls Moderate risk The firm received increased customer complaints for Missing Red Line, Patient S…

Baxter Healthcare Corp. recalls GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dia…

October 12, 2016 · Medical device recalls Moderate risk Potential presence of particulate matter on the blood side of the dialyzer

Baxter Healthcare Corp. recalls V6 Rear Case Assembly, Product Code 35701, a replacement part for the SIGMA Spectrum Infusion Pump -- SIGMA LLC Medina,…

September 28, 2016 · Medical device recalls Moderate risk A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug L…

Baxter Healthcare Corp. recalls sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 Spectrum Infusion Pump, Product Code 35700BAX and…

September 28, 2016 · Medical device recalls Moderate risk A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug L…

Baxter Healthcare Corp. recalls Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump, Product Code 35700BAX2, Unique…

September 28, 2016 · Medical device recalls Moderate risk A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug L…

Baxter Healthcare Corp. recalls Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 cm x 6 cm, product code VG010…

June 24, 2016 · Medical device recalls Moderate risk Baxter is issuing a safety alert in response to postmarketing reports received…

Baxter Healthcare Corp. recalls PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy

May 23, 2016 · Medical device recalls Moderate risk Presence of leaks near top of the PrismaSate bags

Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructions to achieve adjunctive hemo…

May 12, 2016 · Medical device recalls Moderate risk Potential for incomplete dissolution of the polyethylene glycol (PEG) component…

Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructions to achieve adjunctive hemo…

May 12, 2016 · Medical device recalls Moderate risk Potential for incomplete dissolution of the polyethylene glycol (PEG) component…

Baxter Healthcare Corp recalls COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemo…

May 12, 2016 · Medical device recalls Moderate risk Potential for incomplete dissolution of the polyethylene glycol (PEG) component…

Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 2.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2753-FC. Product Usage: The FlowCOUPLER Dev…

April 21, 2016 · Medical device recalls Moderate risk Instructions for use booklet may puncture the outer Tyvek lid.

Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 2.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2752-FC Product Usage: The FlowCOUPLER Devi…

April 21, 2016 · Medical device recalls Moderate risk Instructions for use booklet may puncture the outer Tyvek lid.

Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 3.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2754-FC Product Usage: The FlowCOUPLER Devi…

April 21, 2016 · Medical device recalls Moderate risk Instructions for use booklet may puncture the outer Tyvek lid.

Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 3.5 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2755-FC Product Usage: The FlowCOUPLER Devi…

April 21, 2016 · Medical device recalls Moderate risk Instructions for use booklet may puncture the outer Tyvek lid.

Baxter Healthcare Corp. recalls GEM(TM), FLOWCOUPLER(R), 4.0 mm, STERILE EO, Rx only, 1 FLOWCOUPLER, REF GEM2756-FC Product Usage: The FlowCOUPLER Devi…

April 21, 2016 · Medical device recalls Moderate risk Instructions for use booklet may puncture the outer Tyvek lid.

Baxter Healthcare Corp. recalls Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL…

April 12, 2016 · Drug & medication recalls Moderate risk Discoloration: presence of atypical yellow discoloration of the solution .

Baxter Healthcare Corp. recalls Automated peritoneal dialysis (APD) cycler

February 16, 2016 · Medical device recalls Moderate risk Baxter Healthcare Corporation is sending this communication to inform you of in…

Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Produ…

February 5, 2016 · Drug & medication recalls Moderate risk PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particula…

Baxter Healthcare Corp. recalls Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA,…

January 21, 2016 · Drug & medication recalls High risk Presence of Particulate Matter: identified as a cloth fiber.

Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…

January 21, 2016 · Drug & medication recalls High risk Presence of Particulate Matter: identified as cardboard.

Baxter Healthcare product recalled over sterility concerns

January 21, 2016 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: potential for leaking containers which lacks th…

Baxter Healthcare Corp. recalls CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injectio…

January 21, 2016 · Drug & medication recalls High risk Presence of Particulate Matter: identified as dried skin.

Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare C…

December 15, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Confirmed customer compliants of finding an ins…

Baxter Healthcare Corp. recalls Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must…

December 15, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Confirmed customer compliants of finding an ins…

Baxter Healthcare Corp. recalls Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, Product…

November 30, 2015 · Medical device recalls Moderate risk Potential for dark loose particulate matter (400 microns or smaller) on the spi…

Baxter Healthcare Corp. recalls Baxter CLEARLINK System, Blood Bag Spike Adapter, Luer Activated Valve for I.C. Access, 1C8687, Product Usage: C8687: A…

November 30, 2015 · Medical device recalls Moderate risk Potential for dark loose particulate matter (400 microns or smaller) on the spi…

Baxter Healthcare Corp. recalls Baxter Y-Type Spike Adapter, 7" (18 cm), 1C8433, Product Usage: C8433: For the administration of fluids from a containe…

November 30, 2015 · Medical device recalls Moderate risk Potential for dark loose particulate matter (400 microns or smaller) on the spi…

Baxter Healthcare Corp. recalls Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

October 6, 2015 · Medical device recalls Moderate risk Leakage from the inlet port of the 15L Cycler Drainage Bags.

Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags, Rx only, Baxter Healthcare Corporation, D…

July 17, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Customer complaint for an insect found free flo…

Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter…

July 17, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Customer complaint for an insect found free flo…

Baxter Healthcare product recalled over sterility concerns

July 2, 2015 · Drug & medication recalls Moderate risk Presence of Particulate Matter and Lack of Assurance of Sterility: The firm rec…

Baxter Healthcare Corp. recalls Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for p…

June 29, 2015 · Medical device recalls Loud operating sounds, which was unacceptable to the end users when the device…

Baxter Healthcare Corp recalls Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only,…

June 3, 2015 · Drug & medication recalls Moderate risk Subpotent Drug; out of specification results for heparin raw material

Baxter Healthcare Corp recalls ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT

May 21, 2015 · Medical device recalls Moderate risk Potential for a leak at the tubing to luer bond.

Baxter Healthcare Corp. recalls 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pi…

March 24, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Products recalled due to presence of particulat…

Baxter Healthcare Corp. recalls 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station…

March 24, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Products recalled due to presence of particulat…

Baxter Healthcare Corp. recalls Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Sta…

March 24, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Products recalled due to presence of particulat…

Baxter Healthcare Corp. recalls 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station…

March 24, 2015 · Drug & medication recalls High risk Presence of Particulate Matter: Products recalled due to presence of particulat…

Baxter Healthcare product recalled over sterility concerns

March 23, 2015 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; increased complaints received for leaks

Clinimix E 5/20 sulfite-free Injection recalled over sterility concerns

March 23, 2015 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility; increased complaints received for leaks

5% Dextrose Injection recalled over sterility concerns

March 18, 2015 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility. Complaints were receive of missing closures and…

Baxter Healthcare product recalled over sterility concerns

March 18, 2015 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility. Complaints were receive of missing closures and…

Baxter Healthcare Corp recalls Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump)…

March 2, 2015 · Medical device recalls Moderate risk Loading/Bolus default dose settings in the Master Drug Library and the values s…

Baxter Healthcare Corp. recalls MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

January 22, 2015 · Medical device recalls Moderate risk Product may have separating or protruding sponges

Baxter Healthcare Corp. recalls Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Containers, Approximate Length 85" (2.…

January 14, 2015 · Medical device recalls Moderate risk Potential for failure of the pouch packaging seal at high altitudes.

Fluconazole Injection recalled over sterility concerns

December 23, 2014 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal a…

Baxter Healthcare Corp. recalls Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is…

December 8, 2014 · Medical device recalls Moderate risk Baxter is issuing a recall for one lot of Integrated Automated Peritoneal Dialy…

Baxter Healthcare Corp recalls 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield,…

December 4, 2014 · Drug & medication recalls High risk Presence of Particulate Matter: Confirmed customer complaints received for the…

Baxter Healthcare Corp. recalls HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Product codes 5C8310, 5C8310R,…

October 21, 2014 · Medical device recalls Moderate risk The keypad buttons on HomeChoice devices may be activated without the operator…

Baxter Healthcare Corp. recalls HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice and HomeChoice Pro APD system…

October 6, 2014 · Medical device recalls Moderate risk There are additional and updated warning and cautions that are not in the Patie…

Baxter Healthcare Corp. recalls Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated periton…

April 24, 2014 · Medical device recalls Moderate risk System error 01779 is produced when the battery cannot be charged due to specif…

Baxter Healthcare Corp. recalls The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single use device for the control of…

April 17, 2014 · Medical device recalls Moderate risk Potential for device malfunction resulting in flow when the device should not b…

Baxter Healthcare Corp. recalls AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

April 3, 2014 · Medical device recalls Moderate risk Additional warning in the AMIA APD System labeling for patients vulnerable to u…

The HomeChoice Pro APD System is a peritoneal dialysis system recalled over laceration hazard

October 16, 2013 · Medical device recalls Moderate risk The occluder in affected devices 1) may have sharp edges that could cut the pne…

Baxter Healthcare Corp. recalls 1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2)…

October 7, 2013 · Medical device recalls Moderate risk In systems with version 10.4 software Initial Drain logic, the device will atte…

Baxter Healthcare Corp. recalls MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking…

February 25, 2013 · Medical device recalls Moderate risk Labeling Revision: Additional instructions for the use of peritoneal dialysis t…

Baxter Healthcare Corp. recalls MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for p…

February 25, 2013 · Medical device recalls Moderate risk Labeling Revision: Additional instructions for the use of peritoneal dialysis t…

Baxter Healthcare Corp. recalls CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL pe…

February 25, 2013 · Medical device recalls Moderate risk Labeling Revision: Additional instructions for the use of peritoneal dialysis t…

Baxter Healthcare Corp. recalls MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Ba…

February 25, 2013 · Medical device recalls Moderate risk Labeling Revision: Additional instructions for the use of peritoneal dialysis t…

Baxter Healthcare Corp. recalls Baxter Non-DEHP Micro-Volume Extension Set, Male Luer Lock Adapter, 36 (91 cm), Volume 0.32 mL; an Rx sterile, single u…

December 14, 2012 · Medical device recalls Moderate risk Some of the individual extension set packages were improperly sealed, compromis…