FDA Device recall Z-1345-2021
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells
- FDA Device
- Class II
- terminated
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells by Fenwal, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1345-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-25 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Fenwal |
| Distribution | US |
Product
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Reason
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.
Identifiers
| code_info | Product Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1345-2021%22
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