FDA Device recall Z-1255-2023
Amicus Exchange Kit Therapeutics
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of Amicus Exchange Kit Therapeutics by Fenwal, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1255-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-02-14 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fenwal |
| Distribution | US |
Product
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Reason
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.
Identifiers
| code_info | Product Code X6R2349; UDI: 04086000101950; Batch Numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, F…Product Code X6R2349; UDI: 04086000101950; Batch Numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, FA22K21065. The Lot number coding system is the following: FAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1255-2023%22
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