Fenwal Inc recalls Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform

Recall date

February 14, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1254-2023

FDA classification

Class II

Brand / firm

Fenwal Inc

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform