medical Class II Updated 2021-04-14

Fenwal Inc recalls Amicus Exchange Kit Therapeutics - Product Usage: intended f

Recalled Product

Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)
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