Product Wiki · Recalls · Health Canada — Medical Devices

Cardiohelp-I — recall 74416

Health Canada — Medical Devices · Canada · 2023-10-13 · Type I

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Agency: Health Canada — Medical Devices
Recall identifier: 74416
Date of alert: 2023-10-13
Country / jurisdiction: Canada
Risk level: Type I
Risk type: recall
Product category: Gastroenterology and urology
Product type: Medical devices

Reported risk: 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

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/cardiohelp-1

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Cardiohelp-I — recall 74416

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