BEUDAMED
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    Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Renal Div·August 8, 2012

    Baxter BM11 Blood Monitor Pump hemodialysis machine; Baxter Healthcare Corporation, Deerfield, IL 60015; product code 5M3005, 5M3005R

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KOC·December 21, 2005

    Baxter Arena Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·February 20, 2004

    Baxter Renal Software Suite (Renal Link and PD Link); Baxter Healthcare Corporation, McGaw Park, Illinois 60085

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KPF--·April 12, 2004

    Baxter System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 instruments labeled as System 1000, AltraTouch 1000, Baxter Tina and Baxter Aurora; Baxter Healthcare Corporation, Deerfield, IL 60015 USA or Baxter Healthcare Corporation, McGaw Park, IL 60085 USA

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FII·February 20, 2004

    Baxter Renal Software Suite v.3.0 and v.3.1 - Renal Link HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KPF·November 14, 2007

    Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and double sealing male Luer lock connector; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code R5C4325

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDJ·November 5, 2004

    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·August 31, 2009

    Baxter HomeChoice Automated Peritoneal Dialysis Systems; Catalog Numbers: 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R, 5C4474D and 5C447DR. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·January 8, 2010

    HomeChoice PRO Automated Peritoneal Dialysis Systems; Catalog Numbers; 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, and T5C8300R. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. The HomeChoice PRO model has a PRO card, a small electronic data card, which stores information from the nurse or doctor and automatically sets up the system for the patient.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·January 8, 2010

    Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code S1000L3P. Hemodialysis and Continuous Renal Replacement Therapy devices for acute and chronic hemodialysis

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·September 19, 2011

    Spanish Patient At-Home Guide for the HomeChoice/HomeChoice Pro Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·September 12, 2005

    Accura System for Blood Filtration, product codes 5M5660 and ACCURA01 (international); a hemofiltration system; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085, manufactured in Germany

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·July 13, 2005

    Baxter Arena Hemodialysis Systems, product codes ARENADPX, ARENASP, ARENADPP, ARENASPX; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·June 14, 2005

    HomeChoice PRO and Yume Plus Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, T5C8300, T5C8300R

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·November 1, 2004

    HomeChoice Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474, 5C4474R, T5C4441, T5C4441R

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·June 21, 2005

    System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and Altratouch; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKP·February 24, 2006

    Baxter Healthcare Corporation, RenalSoft Observational Study v.2.0 - HD Module, PD Module and Medical Record Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KPF·March 29, 2006

    Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KDI·October 3, 2003

    Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module; clinical data management software; Baxter Healthcare Corporation, McGaw Park, Illinois 60085

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code KPF·November 14, 2007