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Terminated

APD Set with Cassette 3-Prong Peritoneal Dialysis Set 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 Z-1056-2017 · Posted 2017-01-19

Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFKX
Date Initiated2016-12-16
Date Terminated2017-08-24
Product Quantity8640 eaches

Reason for Recall

Customer complaints received for the presence of leaks

Firm Action

An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.

Root Cause

Device Design

Distribution Pattern

US only

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RBaxter Healthcare Corp · 2011-03-30

Official Source

View FDA Recall →

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

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