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Baxter Healthcare Corp.

354 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product recall (Z-0370-2017)Baxter Healthcare Corp.2016-11-08
Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and product codes: 1 recall (Z-2533-2016)Baxter Healthcare Corp.2016-08-12
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy recall (Z-2049-2016)Baxter Healthcare Corp.2016-06-24
COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructio recall (Z-1838-2016)Baxter Healthcare Corp2016-05-31
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071; For use in vascular reconstructio recall (Z-1839-2016)Baxter Healthcare Corp2016-05-31
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072; For use in vascular reconstructio recall (Z-1840-2016)Baxter Healthcare Corp2016-05-31
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal recall (Z-0291-2016)Baxter Healthcare Corp.2015-11-17
ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NE recall (Z-0132-2016)Baxter Healthcare Corp2015-10-16
MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4 recall (Z-2471-2015)Baxter Healthcare Corp.2015-08-27
MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intende recall (Z-2472-2015)Baxter Healthcare Corp.2015-08-27
MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter L recall (Z-2473-2015)Baxter Healthcare Corp.2015-08-27
CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use recall (Z-2474-2015)Baxter Healthcare Corp.2015-08-27
The Patient Control Module (PCM) is used in conjunction with a Baxter infusor as a single recall (Z-1536-2015)Baxter Healthcare Corp.2015-04-27
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Sp recall (Z-1451-2015)Baxter Healthcare Corp2015-04-16
The HomeChoice Pro APD System is a peritoneal dialysis system. The HomeChoice Pro Automate recall (Z-1292-2015)Baxter Healthcare Corp.2015-03-18
MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis. recall (Z-1269-2015)Baxter Healthcare Corp.2015-03-13
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and ad recall (Z-1245-2015)Baxter Healthcare Corp.2015-03-04
Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product recall (Z-1039-2015)Baxter Healthcare Corp.2015-02-02
HomeChoice/HomeChoice Pro Automated Personal Cycler, for Automated Peritoneal Dialysis. Pr recall (Z-1031-2015)Baxter Healthcare Corp.2015-01-29
Product Code 2C4013, Four Lead TUR Irrigation Set, for use with UROMATIC Plastic Container recall (Z-1010-2015)Baxter Healthcare Corp.2015-01-26
Baxter Amia Automated PD systems are used in the treatment of adult renal failure patients recall (Z-0932-2015)Baxter Healthcare Corp.2015-01-07
HomeChoice Automated PD system and HomeChoice Pro Automated PD system Baxter's HomeChoice recall (Z-0939-2015)Baxter Healthcare Corp.2015-01-07
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixt recall (Z-0084-2015)Baxter Healthcare Corp2014-10-31
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) recall (Z-0085-2015)Baxter Healthcare Corp2014-10-31
15 L Cycler Drainage Bag Product Usage: For use with Baxter Cycler Tubing sets as a perito recall (Z-0080-2015)Baxter Healthcare Corp2014-10-17
SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration o recall (Z-2738-2014)Baxter Healthcare Corp.2014-10-01
***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Chamber Filter Va recall (Z-2613-2014)Baxter Healthcare Corp2014-09-09
***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamber Filter Valv recall (Z-2614-2014)Baxter Healthcare Corp2014-09-09
***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber F recall (Z-2615-2014)Baxter Healthcare Corp2014-09-09
Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation. For recall (Z-2074-2014)Baxter Healthcare Corp.2014-07-17
EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 D recall (Z-1963-2014)Baxter Healthcare Corp.2014-07-01
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. recall (Z-1945-2014)Baxter Healthcare Corp.2014-06-30
SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product Usage: Sigma Spec recall (Z-1484-2014)Baxter Healthcare Corp.2014-04-25
IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL u recall (Z-0607-2014)Baxter Healthcare Corp.2013-12-29
Baxter, VIAL-MATE Adaptor, 2B8071, Rx Only, STERILE R, Baxter Healthcare Corporation, Deer recall (Z-0392-2014)Baxter Healthcare Corp.2013-11-26
SIGMA SPECTRUM Infusion Pump with Master Drug Library component (SHARP LCD screen, 55074-2 recall (Z-0189-2014)Baxter Healthcare Corp.2013-11-08
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the control recall (Z-0197-2014)Baxter Healthcare Corp.2013-11-08
Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports o recall (Z-0143-2014)Baxter Healthcare Corp.2013-11-06
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affilia recall (Z-0109-2014)Baxter Healthcare Corp.2013-10-30
Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Acti recall (Z-0099-2014)Baxter Healthcare Corp.2013-10-29
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices tha recall (Z-1677-2013)Baxter Healthcare Corp.2013-07-10
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices tha recall (Z-1678-2013)Baxter Healthcare Corp.2013-07-10
Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices tha recall (Z-1679-2013)Baxter Healthcare Corp.2013-07-10
Four Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C401 recall (Z-1682-2013)Baxter Healthcare Corp.2013-07-10
Two Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product recall (Z-1683-2013)Baxter Healthcare Corp.2013-07-10
Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Produc recall (Z-1684-2013)Baxter Healthcare Corp.2013-07-10
Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous recall (Z-1600-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of med recall (Z-1601-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intr recall (Z-1602-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medic recall (Z-1603-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medic recall (Z-1604-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration o recall (Z-1605-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medicatio recall (Z-1606-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor recall (Z-1609-2013)Baxter Healthcare Corp.2013-06-27
Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day In recall (Z-1610-2013)Baxter Healthcare Corp.2013-06-27
Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For recall (Z-1565-2013)Baxter Healthcare Corp.2013-06-21
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Lu recall (Z-1268-2013)Baxter Healthcare Corp.2013-05-07
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injec recall (Z-1269-2013)Baxter Healthcare Corp.2013-05-07
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) recall (Z-1270-2013)Baxter Healthcare Corp.2013-05-07
A) Product Code 2N8371: Non-DEHP Y-Type Catheter Extension Set Kit, 6.0", Vol. 1.0 mL, 2 L recall (Z-1271-2013)Baxter Healthcare Corp.2013-05-07
Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber recall (Z-0012-2013)Baxter Healthcare Corp.2012-10-09
Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Val recall (Z-0013-2013)Baxter Healthcare Corp.2012-10-09
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette recall (Z-0014-2013)Baxter Healthcare Corp.2012-10-09
Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette recall (Z-0015-2013)Baxter Healthcare Corp.2012-10-09
Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusi recall (Z-2268-2012)Baxter Healthcare Corp.2012-08-24
Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion recall (Z-2269-2012)Baxter Healthcare Corp.2012-08-24
AUTOMIX High Speed Compounder System, product 2M8077; automated nutrition compounders; Pro recall (Z-2139-2012)Baxter Healthcare Corp.2012-08-08
AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders recall (Z-2140-2012)Baxter Healthcare Corp.2012-08-08
AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated nutriti recall (Z-2141-2012)Baxter Healthcare Corp.2012-08-08
AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated nutrit recall (Z-2142-2012)Baxter Healthcare Corp.2012-08-08
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Health recall (Z-0744-2012)Baxter Healthcare Corp.2012-01-13
Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, recall (Z-0745-2012)Baxter Healthcare Corp.2012-01-13
Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Lue recall (Z-0469-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, 69" (1.8 m), 2 Injection Sites, Male Lue recall (Z-0470-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer recall (Z-0471-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Vented Continu-Flo Solution Set, 100" (2.5 m), Vol. 2.9 mL, 3 Inje recall (Z-0472-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Y-Type Solution Set, 78" (2.0 m), 2 Injection Sites, Male Luer Loc recall (Z-0473-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set with Control-A-Flo Regulator, 89" (2.3 m) recall (Z-0474-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Extension Set, 13" (32 cm), Check Valve, Injection Site, Male Luer recall (Z-0475-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System 3-Port Manifold with Check Valves, Vol. 1.0 mL, Large Bore 4-Way S recall (Z-0476-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, M recall (Z-0477-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, length 89" (2.3 m), 2 Injection Sites, M recall (Z-0478-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Solution Set, 67" (1.7 m), Injection Site, Male Luer Lock Adapter, recall (Z-0479-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Continu-Flo Solution Set, 71" (1.8 m), 2 Injection Sites, Male Lue recall (Z-0480-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Straight Type Blood Set with 40 and 150 Micron Dual Screen Filter, recall (Z-0481-2012)Baxter Healthcare Corp.2012-01-11
Baxter Interlink System Y-Type Blood/Solution Set with 40 and 150 Micron Dual Screen Filte recall (Z-0482-2012)Baxter Healthcare Corp.2012-01-11
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: recall (Z-0598-2012)Baxter Healthcare Corp.2012-01-11
Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, recall (Z-0134-2012)Baxter Healthcare Corp.2011-10-28
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfiel recall (Z-3276-2011)Baxter Healthcare Corp.2011-09-23
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pump. Baxter Healthc recall (Z-3007-2011)Baxter Healthcare Corp.2011-08-11
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Health recall (Z-3008-2011)Baxter Healthcare Corp.2011-08-11
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Health recall (Z-2958-2011)Baxter Healthcare Corp.2011-08-08
Baxter Solution Set with Duo-Vent Spike; 109" (2.8 m), Male Luer Lock Adapter 10 drops/mL. recall (Z-2920-2011)Baxter Healthcare Corp.2011-08-03
Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Health recall (Z-2853-2011)Baxter Healthcare Corp.2011-07-19
Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, I recall (Z-2837-2011)Baxter Healthcare Corp.2011-07-15
Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxt recall (Z-2796-2011)Baxter Healthcare Corp.2011-07-13
Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, sin recall (Z-2708-2011)Baxter Healthcare Corp.2011-06-29
Baxter Interlink System Large Bore 4-Way Stopcock, Volume 0.65 mL, Injection Site, Rotatin recall (Z-2623-2011)Baxter Healthcare Corp.2011-06-22
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfiel recall (Z-2291-2011)Baxter Healthcare Corp.2011-05-25
Baxter Colleague, Colleague CX and Colleague CXE Infusion Pumps, Single Channel Volumetric recall (Z-2222-2011)Baxter Healthcare Corp.2011-05-19
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Every clearance here is in the API, with alerts when new ones post.