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Sources: EU EUDAMED, US FDA
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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
Baxter Amia Automated Peritoneal Dialysis (APD) Cycler Set, REF 5C5479
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FKX·November 15, 2023
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
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
FDA Recall
Completed
·Fresenius Medical Care Holdings, Inc.·Product code FKX·September 12, 2020
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
FDA Recall
Open, Classified
·Baxter Healthcare Corporation·Product code FKX·February 22, 2023
Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and Korea), and 8.13.4 (US, EMEA, and LATAM)
FDA Recall
Open, Classified
·Vantive US Healthcare LLC·Product code FKX·August 28, 2025
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