Z-1344-2021 Class II Terminated
FDA device recall Z-1344-2021 was initiated by Fenwal Inc on February 25, 2021 and is designated Class II. 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 th… The recall status is terminated (terminated April 18, 2023). Affected quantity: 2466 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 14, 2021
- Initiation Date
- February 25, 2021
- Termination Date
- April 18, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2466 units
Product Description
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.
Distribution Pattern
US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.
Code Information
Product Code X6R2339; UDI: 04086000100151; Batch Numbers FA20F08147 (Exp. 06/07/2022), FA20H12145 (Exp. 08/11/2022), FA20J27157 (Exp. 10/26/2022)