Automated Peritoneal Dialysis System — Class II medical device recall Z-1316-2023
Ongoing recall by Baxter Healthcare Corporation, reported 2023-04-05, distributed in AL, AR, AZ, FL, IL, ND, NY, OH…. The electrical safety testing was not properly performed on the impacted devices and additional testing is req
| Recall number | Z-1316-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2023-02-22 |
| Classified | 2023-03-30 |
| Reported by FDA | 2023-04-05 |
| Distributed | AL, AR, AZ, FL, IL, ND, NY, OH, TX, WA |
| Quantity | 16 units |
| UPC / GTIN / UDI-DI | 00085412676463 |
| Serial numbers | 2010013403, 2102050403, 2103016303, 2103061703, 2104009103, 2105007803, 2105022503, 2110006603, 2110034803, 2111034103, 2202044303, 2203059903, 2203071803, 2203073003, 2203109603, 2204078503 |
Product
Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.
Reason for recall
The electrical safety testing was not properly performed on the impacted devices and additional testing is required
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-1316-2023. 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.