Z-1255-2023 Class II Ongoing
FDA device recall Z-1255-2023 was initiated by Fenwal Inc on February 14, 2023 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 6,564 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 22, 2023
- Initiation Date
- February 14, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,564 units
Product Description
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Reason for Recall
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.
Distribution Pattern
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
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.