Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Z-0564-03 · Posted 2003-02-21

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFKX
Date Initiated2002-12-23
Date Terminated2007-12-11

Reason for Recall

Potential for low ultrafiltrate volumes when using the Low Fill Mode during Continuous Cycling Peritoneal Dialysis (CCPD) Therapy

Firm Action

Safety Alert letters dated 12/23/02 were mailed to the medical directos of facilities identified as having patients who use the low fill volume cassette with the HomeChoice machines. The letters informed them of the potential low ultrafiltrate volumes and requested that they review the patient list provided with the letter and verify that all of their patients who use the device in the low fill mode are included.

Root Cause

Other

Distribution Pattern

Nationwide, Guatemala, Chile, Brazil, Turkey, Singapore, Taiwan, Canada, Belgium, Czech Republic, Israel, Italy, Jordan, Lebanon, Malta, Spain, Sweden, Turkey and the United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469Baxter Healthcare Corp · 2001-12-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑