Skip to content
Recall Observatory FDA recall evidence

Device product

Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

Z-1254-2023

February 14, 2023

Class II

Product summary

Firm
Fenwal Inc
Event
Event 91704
Status
Ongoing
Classification
Class II
Quantity
1,614 units
Official record key
device-enforcement:Z-1254-2023

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 X6R2326; UDI: 04086000100144; Batch Numbers: FA22G25121, FA22H22134, FA22I26141, FA22J25225, FA22J31074. 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.