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Baxter Healthcare Corporation

250 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hem recall (Z-0764-2023)Baxter Healthcare Corporation2022-12-22
Hill-Rom Progressa Bed System recall (Z-0231-2023)Baxter Healthcare Corporation2022-11-14
Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-71101-EU, #107003 recall (Z-0175-2023)Baxter Healthcare Corporation2022-11-03
C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-70701, #103001, recall (Z-0176-2023)Baxter Healthcare Corporation2022-11-03
Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #80 recall (Z-0177-2023)Baxter Healthcare Corporation2022-11-03
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to recall (Z-0178-2023)Baxter Healthcare Corporation2022-11-03
Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orth recall (Z-0179-2023)Baxter Healthcare Corporation2022-11-03
Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #800101. To po recall (Z-0180-2023)Baxter Healthcare Corporation2022-11-03
Hillrom Centrella Hospital Bed with WatchCare Incontinence Management System, Product code recall (Z-0141-2023)Baxter Healthcare Corporation2022-10-31
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Centrella Be recall (Z-0142-2023)Baxter Healthcare Corporation2022-10-31
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for Progressa Be recall (Z-0143-2023)Baxter Healthcare Corporation2022-10-31
Hillrom Hospital Bed Accessory, WatchCare Incontinence Management System for VersaCare Bed recall (Z-0144-2023)Baxter Healthcare Corporation2022-10-31
Hillrom Hospital Bed Accessory, Watch Care Incontinence Management System for VersaCare Be recall (Z-0145-2023)Baxter Healthcare Corporation2022-10-31
Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). For use in provid recall (Z-0081-2023)Baxter Healthcare Corporation2022-10-12
Prismaflex M Set: M150 (product code 109990). For use in providing continuous fluid manage recall (Z-0082-2023)Baxter Healthcare Corporation2022-10-12
Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142). For use in recall (Z-0083-2023)Baxter Healthcare Corporation2022-10-12
Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ST150 (product recall (Z-0084-2023)Baxter Healthcare Corporation2022-10-12
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid managemen recall (Z-0085-2023)Baxter Healthcare Corporation2022-10-12
Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same recall (Z-1817-2022)Baxter Healthcare Corporation2022-09-26
Baxter CLEARLINK System, Non-DEHP Solution Set with DUO-VENT Spike, Product Code 2R8403. A recall (Z-1653-2022)Baxter Healthcare Corporation2022-09-14
The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is recall (Z-1570-2022)Baxter Healthcare Corporation2022-08-24
ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Ab recall (Z-1376-2022)Baxter Healthcare Corporation2022-07-22
In-Line ventilator adaptor recall (Z-1138-2022)Baxter Healthcare Corporation2022-05-30
In-Line ventilator adaptor recall (Z-1139-2022)Baxter Healthcare Corporation2022-05-30
Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular procedures. Us recall (Z-1019-2022)Baxter Healthcare Corporation2022-04-29
Baxter Spectrum IQ Infusion Pumps, Product code 3570009. recall (Z-0529-2022)Baxter Healthcare Corporation2022-01-29
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product code 357 recall (Z-0530-2022)Baxter Healthcare Corporation2022-01-29
Dose IQ Safety Software used with Spectrum IQ Infusion Pump recall (Z-2165-2021)Baxter Healthcare Corporation2021-08-11
Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009. for the co recall (Z-2110-2021)Baxter Healthcare Corporation2021-08-06
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6) recall (Z-0120-2021)Baxter Healthcare Corporation2020-10-22
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) recall (Z-0121-2021)Baxter Healthcare Corporation2020-10-22
Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) recall (Z-0122-2021)Baxter Healthcare Corporation2020-10-22
Spectrum IQ Infusion System with Dose IQ Safety Software recall (Z-0123-2021)Baxter Healthcare Corporation2020-10-22
TherMax Blood Warmer Unit recall (Z-0247-2020)Baxter Healthcare Corporation2019-10-30
EXACTAMED Oral Dispensers, 5mL, AMBER: (a) PHARMACY PACK, REF H9388105, x 100; (b) PHARMAC recall (Z-0050-2020)Baxter Healthcare Corporation2019-10-07
EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-vo recall (Z-0363-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large- recall (Z-0364-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-v recall (Z-0365-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-v recall (Z-0366-2019)Baxter Healthcare Corporation2018-11-02
EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-v recall (Z-0367-2019)Baxter Healthcare Corporation2018-11-02
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product recall (Z-1663-2018)Baxter Healthcare Corporation2018-05-04
Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAXL Product recall (Z-1664-2018)Baxter Healthcare Corporation2018-05-04
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXR Product recall (Z-1665-2018)Baxter Healthcare Corporation2018-05-04
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRP Produc recall (Z-1666-2018)Baxter Healthcare Corporation2018-05-04
Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Produc recall (Z-1667-2018)Baxter Healthcare Corporation2018-05-04
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use i recall (Z-0485-2018)Baxter Healthcare Corporation2018-01-11
Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Steri recall (Z-2246-2017)Baxter Healthcare Corporation2017-06-02
APD Set with Cassette 3-Prong Peritoneal Dialysis Set Indicated for use in the treatment o recall (Z-1056-2017)Baxter Healthcare Corporation2017-01-19
FlowCOUPLER. An implantable device that is used to detect blood flow in vessels. Used in t recall (Z-2126-2014)Baxter Healthcare Corporation2014-07-29
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number recall (Z-1490-2012)Baxter Healthcare Corporation2012-06-13
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Every clearance here is in the API, with alerts when new ones post.