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Baxter Healthcare Corp.: Recalls

583 recall records from Jul 31, 2009 to Sep 14, 2026, newest first. Showing 301 to 400.

What this list covers: FDA records filed under the name "Baxter Healthcare Corp." and its spelling variants "Baxter Healthcare", "Baxter Healthcare Corporation", "Baxter Corporation", "Baxter".

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NumberClassProductDate
Z-0578-2022Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Long, REF R5C4484Jan 7, 2022
Z-0577-2022Class IIBaxter MiniCap Extended Life PD Transfer Set Twist Clamp - Extra Short, REF R5C4483Jan 7, 2022
Z-0576-2022Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482EJan 7, 2022
Z-0575-2022Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, REF R5C4482Jan 7, 2022
Z-0574-2022Class IIBaxter Equipo de transferencia para DP MiniCap de vida util prolongada con pinza de torsion…Jan 7, 2022
Z-0573-2022Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482EJJan 7, 2022
Z-0572-2022Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short, 5C4483Jan 7, 2022
Z-0571-2022Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, 5C4482Jan 7, 2022
Z-0570-2022Class IIBaxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449Jan 7, 2022
Z-0530-2022Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 35700BAX2.Dec 29, 2021
Z-0529-2022Class IBaxter Spectrum IQ Infusion Pumps, Product code 3570009.Dec 29, 2021
Z-0215-2022Class IIHemodialysis Delivery System, Software Version 2.x.Sep 29, 2021
Z-2379-2021Class IIBaxter prismaflex, HF 1000 PAES membrane, REF 107140 Used with Prismaflex or PrisMax control…Jul 22, 2021
Z-2378-2021Class IIBaxter PrismaFlex, REF numbers: a) 106696 (M 60 SET) b) 106697 (M 100 SET) Expansion: c)…Jul 22, 2021
Z-2165-2021Class IDose IQ Safety Software used with Spectrum IQ Infusion PumpJul 7, 2021
Z-2174-2021Class IIKaguya Automated Peritoneal Dialysis SystemJun 30, 2021
Z-2173-2021Class IISharesource Connectivity Platform for Use with the Amia Automated PD SystemJun 30, 2021
Z-2051-2021Class IIEASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.Jun 15, 2021
Z-2110-2021Class ISpectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the controlled…Jun 4, 2021
Z-1684-2021Class IIGambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a…Apr 14, 2021
Z-1487-2021Class IISpectrum IQ - Infusion Pump - Product Usage: intended to be used for the controlled administration…Mar 19, 2021
Z-1280-2021Class IIPreventative Maintenance Kits G5010007) and spare part kits (G5064801 and G5006203) - Product Usage…Jan 28, 2021
Z-1279-2021Class IIPrismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).Jan 28, 2021
Z-1278-2021Class IIPrismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).Jan 28, 2021
Z-1277-2021Class IIPrismaflex Control Unit - Product Usage: Used for Continuous Renal Replacement Therapy (CRRT).Jan 28, 2021
Z-1151-2021Class IIThe PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump…Jan 7, 2021
Z-1150-2021Class IIInfusion PumpJan 6, 2021
Z-1123-2021Class IIGambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set, product…Dec 30, 2020
Z-1122-2021Class IIGambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set, product code 114434…Dec 30, 2020
Z-1121-2021Class IIGambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 109536 - Product…Dec 30, 2020
Z-1120-2021Class IIGambro Cartridge Blood Transport System for Hemodialysis Blood Set, product code 106289 - Product…Dec 30, 2020
Z-1119-2021Class IIGambro Cartridge Single Needle Conversion Kit, product code 101290 - Product Usage: intended for…Dec 30, 2020
Z-1118-2021Class IIGambro Cartridge Blood Set Prime Line, product code 101025 - Product Usage: intended for single use…Dec 30, 2020
Z-0939-2021Class IIFLOW COUPLER Monitor Flow Coupler devices are sold in 5 sizes (2.0 mm, 2.5 mm, 3.0 mm, 3.5 mm, 4.0…Dec 28, 2020
Z-1102-2021Class IIBaxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector…Dec 21, 2020
Z-0807-2021Class IIVERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor…Dec 11, 2020
Z-0715-2021Class IIBaxter Spectrum IQ Infusion System with Dose IQ Safety Software - Product Usage: intended to be used…Nov 23, 2020
Z-0714-2021Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) - Product Usage: intended…Nov 23, 2020
Z-0713-2021Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended…Nov 23, 2020
Z-0712-2021Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) - Product Usage: intended…Nov 23, 2020
Z-0768-2021Class IIMiniCap Extended Life PD Transfer SetNov 10, 2020
D-0076-2021Class IIBupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL…Oct 7, 2020
Z-0123-2021Class ISpectrum IQ Infusion System with Dose IQ Safety SoftwareJun 30, 2020
Z-0122-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)Jun 30, 2020
Z-0121-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8)Jun 30, 2020
Z-0120-2021Class IBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)Jun 30, 2020
Z-2474-2020Class IIFlow Coupler Monitor, GEM, Global Excellence Microsurgery, Rx OnlyJun 2, 2020
Z-2196-2020Class IIGambro Cartridge Low Weight-Low Volume Blood Transport System for Hemodialysis Blood Set - Product…Apr 17, 2020
Z-2195-2020Class IIGambro Cartridge Low Volume Blood Transport System for Hemodialysis Blood Set - Product Usage: is…Apr 17, 2020
Z-2194-2020Class IIGambro Cartridge Blood Transport System for Hemodialysis Blood Set - Product Usage: is intended for…Apr 17, 2020
Z-2193-2020Class IIGambro Cartridge Blood Set Prime Line - Product Usage: is intended for single use in a hemodialysis…Apr 17, 2020
Z-2066-2020Class IIPrismaflex Control UnitApr 7, 2020
Z-1687-2020Class IIGEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and…Mar 5, 2020
Z-1686-2020Class IIGEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the…Mar 5, 2020
Z-1685-2020Class IIGEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the…Mar 5, 2020
Z-1833-2020Class IIPrismaflex System, Prismaflex Control UnitFeb 6, 2020
Z-1832-2020Class IIPrismaflex System, Prismaflex Control UnitFeb 6, 2020
Z-1831-2020Class IIPrismaflex System, Prismaflex Control UnitFeb 6, 2020
Z-1830-2020Class IIPrismaflex System, Prismaflex Control UnitFeb 6, 2020
Z-1829-2020Class IIPrismaflex System, Prismaflex Control UnitFeb 6, 2020
Z-1828-2020Class IIPrismaflex System, Prismaflex Control UnitFeb 6, 2020
Z-0794-2020Class IIONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K…Dec 12, 2019
Z-0793-2020Class IIClearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541…Dec 12, 2019
D-0517-2020Class II0.9% Sodium Chloride Irrigation USP 5000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield…Nov 19, 2019
Z-1409-2020Class IIRevaclear Capillary Dialyzer 300, REF Revaclear 300 Product Code 114745LNov 15, 2019
Z-0280-2020Class IIPrismaflex Control Unit, software versions below 7.21Oct 4, 2019
Z-0279-2020Class IIPrismaflex Control Unit, software versions below 7.21Oct 4, 2019
Z-0278-2020Class IIPrismaflex Control Unit, software versions below 7.21Oct 4, 2019
Z-0277-2020Class IIPrismaflex Control Unit, software versions below 7.21Oct 4, 2019
Z-0276-2020Class IIPrismaflex Control Unit, software versions below 7.21Oct 4, 2019
Z-0247-2020Class IITherMax Blood Warmer UnitSep 19, 2019
Z-0167-2020Class IIEXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes…Sep 18, 2019
Z-0050-2020Class IIIEXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMACY PACK…Aug 13, 2019
D-1514-2019Class II0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare…Jul 18, 2019
Z-2432-2019Class IIIEXACTAMED Oral Dispensers, 5mL, AMBER: PHARMACY PACK, REF H9388505, x500 PHARMACY PACK, REF…Jun 27, 2019
D-1435-2019Class IISevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured for Baxter Healthcare…Jun 13, 2019
Z-1909-2019Class IIREVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are…May 31, 2019
Z-1908-2019Class IIREVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are…May 31, 2019
D-0351-2019Class IIDianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose, 2000 mL UltraBag…Jan 2, 2019
Z-0850-2019Class IIKaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control…Dec 11, 2018
Z-0849-2019Class IIAMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control…Dec 11, 2018
Z-0680-2019Class IIGEM Coupler Forceps, GEM4183C, packaged individually.Nov 2, 2018
D-0222-2019Class IIIMetoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx…Oct 15, 2018
Z-0030-2020Class IIL5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized…Oct 10, 2018
D-1215-2018Class IIILevofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL…Sep 25, 2018
Z-0107-2019Class IISPECTRUM IQ INFUSION SYSTEM WITH DOSE IQ SAFETY SOFTWARE, 3570009Sep 18, 2018
Z-0367-2019Class IIEXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume…Sep 12, 2018
Z-0366-2019Class IIEXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume…Sep 12, 2018
Z-0365-2019Class IIEXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume…Sep 12, 2018
Z-0364-2019Class IIEXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume…Sep 12, 2018
Z-0363-2019Class IIEXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume…Sep 12, 2018
D-1190-2018Class II0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield…Sep 6, 2018
D-1128-2018Class II0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL…Aug 21, 2018
D-1036-2018Class IIILevofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single…Aug 1, 2018
D-1035-2018Class IIILevofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single…Aug 1, 2018
D-1034-2018Class IIILevofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single…Aug 1, 2018
Z-2597-2018Class IIpower cord for: (a) AMIA Automated PD Cycler, Product Code: 5C9320; (b) Kaguya PD System, Product…Jul 12, 2018
Z-1248-2019Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), product code 35700BAX…Jun 21, 2018
Z-2957-2018Class IIFLOSEAL Special Applicator Tips in cartons labeled in part, "Floseal SPECIAL APPLICATOR TIPS***6 x…May 30, 2018
Z-2113-2018Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), infusion pump, 35700BAX2…May 8, 2018

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.