Fenwal Inc recalls Amicus Exchange Kit - Product Usage: intended for use in the
Recalled Product
Amicus Exchange Kit - 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
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