Health product recall

Amicus Exchange and Mononuclear Cell Apheresis Kits

Last updated

Summary

Product
Amicus Exchange and Mononuclear Cell Apheresis Kits
Issue
Medical devices - Performance issue
What to do

Contact manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Amicus Exchange Kit - Therapeutics

FA22E23138

X6R2349

Amicus Mononuclear Cell Apheresis Kit - Double Needle

FA22G25121
FA22K23046
FA22J25225

X6R2326

Issue

Potential leaks in the therapeutic centrifuge pack (bottom channel of the separation chamber) have been discovered during collection/exchange process.

Recall start date: February 24, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Haematology
Companies

Fresenius Kabi Ag

Else-Kroner Str. 1, Bad Homburg, Germany, 61346

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-73006

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