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Fenwal Inc recalls Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear
Recalled April 14, 2021 · FDA recall Z-1345-2021 · Fenwal
Hazard
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. · FDA Class II
Units
24 units
Sold at
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.
Description
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.
Product
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Manufacturer(s)
Fenwal Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →