Device product
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Z-1255-2023
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
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.