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Z-2609-2016 Class II Terminated

Recalled by Baxter Healthcare Corp. — Deerfield, IL

FDA device recall Z-2609-2016 was initiated by Baxter Healthcare Corp. on Oct 7, 2013 and is designated Class II. Reason for recall: In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass… The recall status is terminated (terminated Dec 23, 2016). Affected quantity: *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R…

Recall Details

Product Type: Devices
Report Date: Aug 31, 2016
Initiation Date: Oct 7, 2013
Termination Date: Dec 23, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: *** 1) Product Codes 5C4471 and 5C4471R: Approximately 48,600 units; *** 2) Product Codes 5C8310 and 5C8310R: Approxiamtely 16,990 units

Product Description

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.

Reason for Recall

In systems with version 10.4 software Initial Drain logic, the device will attempt to drain the patient to empty at the beginning of therapy (initial drain). The operator can stop, but cannot bypass, the active Initial Drain. This is to mitigate against Unintended Increased Intraperitoneal Volume (IIVP). This can cause serious problems in patients with unrelated a co-morbid condition of ascites.

Distribution Pattern

Worldwide distribution. US nationwide including Puerto Rico; Australia, Canada, New Zealand, and Japan

Code Information

*** 1) HomeChoice automated peritoneal dialysis system: Product Codes: 5C4471 and 5C4471R; Serial Numbers: All serial numbers; *** 2) HomeChoice Pro automated peritoneal dialysis system: Product Codes: 5C8310 and 5C8310R; Serial Numbers: All serial numbers

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2609-2016
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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