Fenwal Inc: Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

Hazard

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.

Details from the source

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. Quantity: 6,564 units 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.

UPC codes

04086000101950

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.