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Health Canada Medical devices

Cardiohelp-I

Issued October 13, 2023
Issue
During a complaint investigation it was reported that the rotation of the Cardiohelp Emergency Drive hand crank was blocked or impaired. In course of internal investigations, it was found that the safety washer causes this issue. The safety washer was originally introduced to the Cardiohelp Emergency Drive in order to lengthen the shaft of the emergency drive by the thickness of the safety washer reducing the axial pressure on the circlip, safety washer and bearing. (serial # specific) Recall start date: October 5, 2023
Hazard description
Performance
Product
Product name
Cardiohelp-I
Reference
ID
RA-74416