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Baxter Healthcare Renal Div

46 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL recall (Z-2132-2012)Baxter Healthcare Renal Div2012-08-02
Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Cor recall (Z-0173-2012)Baxter Healthcare Renal Div2011-11-07
Quinton BETA-CAP Adapter; a Peritoneal Dialysis accessory to the PD catheter used to conne recall (Z-2747-2011)Baxter Healthcare Renal Div2011-07-06
APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Auto recall (Z-2129-2011)Baxter Healthcare Renal Div2011-05-03
Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, De recall (Z-1322-2010)Baxter Healthcare Renal Div2010-04-12
Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, recall (Z-0799-2010)Baxter Healthcare Renal Div2010-03-01
HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5 recall (Z-0800-2010)Baxter Healthcare Renal Div2010-03-01
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA an recall (Z-0179-2010)Baxter Healthcare Renal Div2009-11-12
Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, recall (Z-0946-2008)Baxter Healthcare Renal Div2008-03-07
HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5 recall (Z-0947-2008)Baxter Healthcare Renal Div2008-03-07
Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data manage recall (Z-0527-2008)Baxter Healthcare Renal Div2008-01-26
Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data manageme recall (Z-0528-2008)Baxter Healthcare Renal Div2008-01-26
Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corpo recall (Z-0169-2007)Baxter Healthcare Renal Div2006-11-14
Ultra-Filtration (UF) Removal Regulators(Rgltr Assy UF REM Molded Spare); a spare part use recall (Z-1253-06)Baxter Healthcare Renal Div2006-07-25
Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module recall (Z-0831-06)Baxter Healthcare Renal Div2006-05-03
Baxter Healthcare Corporation, RenalSoft v.1.1 - PD Module; clinical data management softw recall (Z-0832-06)Baxter Healthcare Renal Div2006-05-03
Baxter Healthcare Corporation, Renal Software Suite v.3.1 - HD Module; clinical data manag recall (Z-0833-06)Baxter Healthcare Renal Div2006-05-03
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA an recall (Z-0766-06)Baxter Healthcare Renal Div2006-04-18
Baxter BM25 System ultrafiltration hemodialysis machine; The BM25 System is composed of a recall (Z-0679-06)Baxter Healthcare Renal Div2006-03-29
Baxter BM11A Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerf recall (Z-0680-06)Baxter Healthcare Renal Div2006-03-29
Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfi recall (Z-0681-06)Baxter Healthcare Renal Div2006-03-29
System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA an recall (Z-0347-06)Baxter Healthcare Renal Div2006-01-06
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthca recall (Z-0275-06)Baxter Healthcare Renal Div2005-12-14
Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialy recall (Z-0139-06)Baxter Healthcare Renal Div2005-11-16
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a h recall (Z-0153-06)Baxter Healthcare Renal Div2005-11-16
Baxter System 1000 Single Patient Hemodialysis Systems, product codes SYS1000L3, SYS1000L3 recall (Z-1394-05)Baxter Healthcare Renal Div2005-08-24
Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Ba recall (Z-1395-05)Baxter Healthcare Renal Div2005-08-24
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a h recall (Z-1380-05)Baxter Healthcare Renal Div2005-08-18
HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corpo recall (Z-1018-05)Baxter Healthcare Renal Div2005-07-19
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare C recall (Z-1019-05)Baxter Healthcare Renal Div2005-07-19
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthca recall (Z-0947-05)Baxter Healthcare Renal Div2005-06-30
HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare C recall (Z-0397-05)Baxter Healthcare Renal Div2005-01-15
System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM recall (Z-0367-05)Baxter Healthcare Renal Div2004-12-24
Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m recall (Z-0301-05)Baxter Healthcare Renal Div2004-12-09
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthca recall (Z-0299-05)Baxter Healthcare Renal Div2004-12-08
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series recall (Z-0395-05)Baxter Healthcare Renal Div2004-12-02
HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthc recall (Z-0188-05)Baxter Healthcare Renal Div2004-11-11
HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxte recall (Z-0189-05)Baxter Healthcare Renal Div2004-11-11
Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a h recall (Z-1338-04)Baxter Healthcare Renal Div2004-08-11
Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series recall (Z-0583-04)Baxter Healthcare Renal Div2004-07-20
Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, recall (Z-0584-04)Baxter Healthcare Renal Div2004-07-20
Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthca recall (Z-0758-04)Baxter Healthcare Renal Div2004-07-20
Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw recall (Z-0901-04)Baxter Healthcare Renal Div2004-07-20
Renalsoft software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085 recall (Z-0902-04)Baxter Healthcare Renal Div2004-07-20
HomeChoice and Yume Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthc recall (Z-1012-04)Baxter Healthcare Renal Div2004-07-20
HomeChoice PRO and Yume PlusAutomated Peritoneal Dialysis Systems; Manufactured for Baxter recall (Z-1013-04)Baxter Healthcare Renal Div2004-07-20

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Every clearance here is in the API, with alerts when new ones post.