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Health Canada Medical devices

Cardiohelp-I

Issued February 28, 2022
Issue
Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the drive during inter/intra-hospital transportation if no sprinter cart/ sprinter cart xl is used. The detected nonconformity is restricted only to transport guards distributed with specific serial numbers of Cardiohelp-I. Recall start date: Feb 22, 2022
Hazard description
Manufacturing defect
Product
Product name
Cardiohelp-I
Reference
ID
RA-63949