FDA recall Z-1255-2023

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2023-02-14

Report date

2023-03-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1255-2023