Z-1345-2021 Class II Terminated
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
- 24 units
Product Description
Amicus Exchange Kit Therapeutics - 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 X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)