AMIA v1 — Class II medical device recall Z-1245-2015
Terminated recall by Baxter Healthcare Corp., reported 2015-03-11, distributed nationwide. Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperito
| Recall number | Z-1245-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corp., Deerfield, IL, United States |
| Recall initiated | 2014-04-03 |
| Classified | 2015-03-04 |
| Reported by FDA | 2015-03-11 |
| Terminated | 2017-07-21 |
| Distributed | Nationwide (US) |
| Quantity | 55 systems |
| Reason classes | labeling |
Product
AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Reason for recall
Additional warning in the AMIA APD System labeling for patients vulnerable to unintended Increased Intraperitoneal Volume (IIPV), also known as overfill. The patients include neonates, infants, small children, and any patient with significant heart and/or lung disease.
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-1245-2015. 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.