Gambro Cartridge Blood Set — Class II medical device recall Z-1684-2021
Terminated recall by Baxter Healthcare Corporation, reported 2021-06-02. There is a potential leak between the venous patient connector and patient's hemodialysis access.
| Recall number | Z-1684-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Baxter Healthcare Corporation, Deerfield, IL, United States |
| Recall initiated | 2021-04-14 |
| Classified | 2021-05-26 |
| Reported by FDA | 2021-06-02 |
| Terminated | 2024-05-10 |
| Countries outside the US | CA, KR, NO |
| Quantity | 17,487 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 37332414007837 |
| Lot numbers | 1000276191 |
Product
Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
Reason for recall
There is a potential leak between the venous patient connector and patient's hemodialysis access.
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-1684-2021. 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.