BEUDAMED
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    HomeChoice PRO Automated Peritoneal Dialysis Systems; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in U.S.A.; catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R, T5C8300, T5C8300R

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt·Product code FKX·December 23, 2002

    Automated peritoneal dialysis (APD) cycler

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·February 16, 2016

    AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FKX·December 11, 2018

    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 Amia Automated PD systems are used in the treatment of adult renal failure patients to perform automated peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·April 24, 2014

    Kaguya Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FKX·December 11, 2018

    Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216

    FDA Recall
    Terminated ·Fresenius Medical Care Renal Therapies Group, LLC·Product code FKX·May 29, 2019

    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 Corp. Rt·Product code FKX·December 23, 2002

    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

    1) The HomeChoice automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. 2) The HomeChoice PRO automated peritoneal dialysis system. Dataplate located on the device is labeled in part: Baxter. The HomeChoice/HomeChoice Pro Automated Personal Cycler peritoneal dialysis system is intended for automatic control of dialysate solution exchange in the treatment of pediatric and adult renal failure patients undergoing peritoneal dialysis.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·October 7, 2013

    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

    Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FKX·October 14, 2013

    Baxter Amia Automated Peritoneal Dialysis Set with Cassette, REF 5C5479

    FDA Recall
    Terminated ·Baxter Healthcare Corp·Product code FKX·September 1, 2017

    L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile, nonpyrogenic fluid path. Sterilized by ethylene oxide.

    FDA Recall
    Terminated ·Baxter Healthcare Corporation·Product code FKX·October 10, 2018

    APD Disposable Sets and Extension Sets used with Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; 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.

    FDA Recall
    Terminated ·Baxter Healthcare Renal Div·Product code FKX·March 16, 2011

    Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.

    FDA Recall
    Terminated ·Fresenius Medical Care Holdings, Inc.·Product code FKX·June 3, 2013

    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use settings.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·December 8, 2014

    Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.

    FDA Recall
    Terminated ·Baxter Healthcare Corp.·Product code FKX·June 29, 2015