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Recall Observatory FDA recall evidence

Device product

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

Z-1255-2023

February 14, 2023

Class II

Product summary

Firm
Fenwal Inc
Event
Event 91704
Status
Ongoing
Classification
Class II
Quantity
6,564 units
Official record key
device-enforcement:Z-1255-2023

Official wording

Reason: 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.

Code information: Product Code X6R2349; UDI: 04086000101950; Batch Numbers: FA22E23138, FA22F28168, FA22G28018, FA22H22225, FA22J28062, FA22K21065. The Lot number coding system is the following: FAXXYaabbc; FA = Haina (manufacturing / production unit); XX = two digit year; Y= letter of the alphabet corresponding to the month; aa= day; bb= sequential number; c= check digit.

Distribution pattern: Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.