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Rotaflow centrifugal pump with bioline
Official notice
9 Jan 2024
Last checked
9 Jan 2024
An official Health Canada notice concerns Rotaflow centrifugal pump with bioline. 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 Published 2024-01-09.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74887
Official notice
2024-01-09
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Maquet Cardiopulmonary, Rotaflow Centrifugal Pump With Bioline.
Source & status
Source & status
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Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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