Amicus Exchange Kit — Class II medical device recall Z-1344-2021
Terminated recall by Fenwal Inc, reported 2021-04-14, distributed nationwide. Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on
| Recall number | Z-1344-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fenwal Inc, Lake Zurich, IL, United States |
| Recall initiated | 2021-02-25 |
| Classified | 2021-04-02 |
| Reported by FDA | 2021-04-14 |
| Terminated | 2023-04-18 |
| Distributed | Nationwide (US) |
| Quantity | 2,466 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04086000100151 |
| Lot numbers | FA20F08147 |
| Expiration dates | 2022-06-07, 2022-08-11, 2022-10-26 |
Product
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Reason for recall
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
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-1344-2021. 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.