FDA-Device2021-04-14Class II
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Fenwal Inc
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.
Sold states
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.
Affected count
2466 units
Manufactured in
3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, United States
Products
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1344-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief