Product Wiki · Recalls · Health Canada — Medical Devices

Venous Hardshell Cardiotomy Reservoir (2019-09-12) — recall 59604

Health Canada — Medical Devices · Canada · 2019-09-20 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59604
Date of alert
2019-09-20
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: During verification testing of Adult/Small Adult VKMOs and VHK a potential impairment of the sterile packaging pouches of the accessories was detected, for products manufactured after March 4th 2019. Under unfavorable transport conditions, excessive movement of the device and its accessories in the carton can lead to stress points that could compromise the sterile barrier of the packaging pouches.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/venous-hardshell-cardiotomy-re

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