Amicus MNC Apheresis Kit - Double Needle - 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 is recalling certain lots of Amicus MNC Apheresis and Amicus Exchange kits used for collecting blood components and mononuclear cells. The recalled kits can develop leaks in the centrifuge pack during procedures on the Amicus Separator when using therapeutic protocols. The blood leaks occur at the boot, elbow, or channel on the separation chamber of the centrifuge pack. A total of 4,488 units were distributed nationwide across multiple states including Georgia, Texas, Tennessee, Maryland, California, Kansas, Minnesota, Massachusetts, and others.
The recalled kits have product code X6R2326 and UDI 04086000100144, with four specific batch numbers affected: FA20E25234 (expiration 05/31/2022), FA20F23120 (expiration 06/30/2022), FA20I21268 (expiration 09/30/2022), and FA20J19246 (expiration 10/31/2022). The recall notice does not specify a remedy 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: 4488 units Lot/code info: Product Code X6R2326; UDI: 04086000100144; Batch Numbers FA20E25234 ((Exp. 05/31/2022), FA20F23120 (Exp. 06/30/2022), FA20I21268 (Exp. 09/30/2022), and FA20J19246 (Exp. 10/31/2022).
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.