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Fenwal Inc recalls Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Recalled March 22, 2023 · FDA recall Z-1255-2023 · Fenwal
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. · FDA Class II
Units
6,564 units
Sold at
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Description
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.
Product
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Manufacturer(s)
Fenwal Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →