FDA-Device2023-03-22Class II
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Fenwal Inc
Hazard
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Sold states
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Affected count
1,614 units
Manufactured in
3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, United States
Products
Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1254-2023Don't want to check this manually?
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