Rotaflow Centrifugal Pump With Bioline
Brand(s)
Last updated
Summary
Product
Rotaflow Centrifugal Pump With Bioline
Issue
Medical devices - Sterility
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected products |
Lot or serial number |
Model or catalogue number |
|---|---|---|
Rotaflow Centrifugal Pump With Bioline |
3000323073 |
BEQ-RF-32 |
Issue
During retrospective internal testing, MCP/Getinge discovered narrow channels in the seal of the sterile bags used to package the RF-32. MCP/Getinge receives this sterile bag from a supplier that performs tests to verify sterility. Incomplete sealing can potentially lead to a breach of the sterile barrier.
Recall start date: December 22, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies
| Maquet Cardiopulmonary Gmbh |
| Kehler Strasse 31, Rastatt, Germany, 76437 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74887
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