Amicus Exchange Kit - 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 2,466 units of Amicus MNC Apheresis and Amicus Exchange kits used for blood component and mononuclear cell collection. The recalled kits, which are used with the Amicus Separator device, may develop blood leaks at the boot, elbow, or channel of the separation chamber's centrifuge pack during therapeutic procedures. The affected products are identified by Product Code X6R2339 and UDI 04086000100151, with three specific batch numbers: FA20F08147 (expiring 06/07/2022), FA20H12145 (expiring 08/11/2022), and FA20J27157 (expiring 10/26/2022). The recalled kits were distributed nationwide across 22 states including California, Texas, Florida, New York, and Pennsylvania.
The recall notice does not specify a remedy or corrective action for consumers to take.
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: 2466 units Lot/code info: Product Code X6R2339; UDI: 04086000100151; Batch Numbers FA20F08147 (Exp. 06/07/2022), FA20H12145 (Exp. 08/11/2022), FA20J27157 (Exp. 10/26/2022)
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.