FDA Device recall Z-2609-2016
1) The HomeChoice automated peritoneal dialysis system
- FDA Device
- Class II
- terminated
- Published 2016-08-31
On 2016-08-31 the FDA classified a Class II recall of 1) The HomeChoice automated peritoneal dialysis system by Baxter Healthcare, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2609-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-07 |
| Published | 2016-08-31 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Baxter Healthcare |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | *** 1) HomeChoice automated peritoneal dialysis system: Product Codes: 5C4471 and 5C4471R; Serial Numbers: All seri…*** 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2609-2016%22
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