Fenwal Inc: Amicus MNC Apheresis Kit Double Needle. 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: 1,614 units Lot/code info: Product Code X6R2326; UDI: 04086000100144; Batch Numbers: FA22G25121, FA22H22134, FA22I26141, FA22J25225, FA22J31074. 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

04086000100144

Source

Official record: FDA (Device enforcement) ↗

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