The HomeChoice Pro APD System is a peritoneal dialysis system — Class II medical device recall Z-1292-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-03-25, distributed nationwide. The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the
| Recall number | Z-1292-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Round Lake, IL, United States |
| Recall initiated | 2013-10-16 |
| Classified | 2015-03-18 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2017-07-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, MX |
| Quantity | 75 units |
| Serial numbers | 680416, 680418, 680420, 680421, 680422, 680424, 680426, 680427, 680428, 680429, 680430, 680438, 680439, 680440, 680441, 680444, 680445, 680448, 680449, 680452, 680453, 680454, 680455, 680456, 680457 and 121 more |
Product
The HomeChoice Pro APD System is a peritoneal dialysis system. The 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
The occluder in affected devices 1) may have sharp edges that could cut the pneumatic tubing that connects the occluder blade to the manifold causing an unrecoverable system error, and/or 2) blade may separate from the back plate and cause Slow / No Flow alarm requiring therapy termination.
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-1292-2015. 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.