Baxter HomeChoice and HomeChoice Pro APD systems — Class III medical device recall Z-0291-2016
Terminated recall by Baxter Healthcare Corp., reported 2015-11-25, distributed nationwide. Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice
| Recall number | Z-0291-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2015-06-29 |
| Classified | 2015-11-17 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-01-24 |
| Distributed | Nationwide (US) |
| Quantity | 29,355 |
Product
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Reason for recall
Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0291-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.