5 Prong Manifold Set — Class II medical device recall Z-1143-2022
Terminated recall by Baxter Healthcare Corporation, reported 2022-06-08, distributed nationwide. Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the
| Recall number | Z-1143-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2022-04-21 |
| Classified | 2022-05-27 |
| Reported by FDA | 2022-06-08 |
| Terminated | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 180 units |
| UPC / GTIN / UDI-DI | 00085412008691 |
| Lot numbers | H17D26065, H17I18046, H18C20051, H19J24041 |
| Expiration dates | 2022-04-26, 2022-09-18, 2023-03-20, 2024-10-24 |
Product
5 Prong Manifold Set (with Luer Connectors)
Reason for recall
Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.
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-1143-2022. 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.