Fenwal Inc recalls Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclea…

Recall date

February 25, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1345-2021

FDA classification

Class II

Brand / firm

Fenwal Inc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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