Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
- Company
- Fenwal Inc
- Recall Initiated
- February 14, 2023
- Posted
- March 15, 2023
- Recall Number
- Z-1255-2023
- Quantity
- 6,564 units
- Firm Location
- Lake Zurich, IL
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
Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
Fresenius Kabi notified customers on 02/14/2023 via FedEx overnight delivery. Customers were instructed to evaluate affected inventory on site for potential continued use according to the conditions in the letter, inform potential users of affected product within the facility and any customers if further distributed, complete and return the acknowledgment form, and report any issues.