Amicus Exchange and Mononuclear Cell Apheresis Kits
Brand(s)
Last updated
Summary
Product
Amicus Exchange and Mononuclear Cell Apheresis Kits
Issue
Medical devices - Performance
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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