Amicus Exchange Kit (Fenwal) – Potential Stress Leak (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Brand
Fenwal Inc
Lot Codes / Batch Numbers
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.
Products Sold
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.
Fenwal Inc is recalling Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026