Fenwal Inc: Medical Device Recall in 2023 - (Recall #: Z-1255-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform

Product Classification:

Class II

Date Initiated: February 14, 2023

Date Posted: March 22, 2023

Recall Number: Z-1255-2023

Event ID: 91704

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.

Status: Ongoing

Product Quantity: 6,564 units

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.

Distribution Pattern:

Nationwide distribution. International distribution to France, Korea, Taiwan, Colombia, India, Brazil, Germany, Canada.

Voluntary or Mandated:

Voluntary: Firm initiated