Amicus MNC Apheresis Kit Double Needle — Class II medical device recall Z-1254-2023
Ongoing recall by Fenwal Inc, reported 2023-03-22, distributed nationwide. Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicu
| Recall number | Z-1254-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fenwal Inc, Lake Zurich, IL, United States |
| Recall initiated | 2023-02-14 |
| Classified | 2023-03-15 |
| Reported by FDA | 2023-03-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CO, DE, FR, IN, KR, TW |
| Quantity | 1,614 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 04086000100144 |
| Lot numbers | FA22G25121, FA22H22134, FA22I26141, FA22J25225, FA22J31074 |
Product
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Reason for recall
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
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-1254-2023. 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.