Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Check against the official notice below — it lists the full affected range.
Fenwal Inc. has recalled 24 units of Amicus MNC Apheresis and Amicus Exchange kits due to leaking centrifuge packs that occur during procedures on the Amicus Separator when using therapeutic protocols. The blood leaks originate at the boot, elbow, or channel on the separation chamber of the centrifuge pack. The affected lots include Batch Numbers FA20E25150 (expiring 05/31/2022) and FA20I22142 (expiring 09/30/2022), with Product Code X6R2349 and UDI 04086000101950. These kits were distributed nationwide across 22 states including Georgia, Texas, Tennessee, Maryland, California, and others.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: 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. Quantity: 24 units Lot/code info: Product Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.