Product Wiki · Recalls · Health Canada — Medical Devices

CUSTOM HEART LUNG PACKS (2016-01-29) — recall 54914

Health Canada — Medical Devices · Canada · 2016-02-22 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54914
Date of alert
2016-02-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Sorin Group USA received a safety alert from Terumo CVS for their CDI H/S Cuvette which is included in custom heart lung packs manufactured by Sorin Group USA. This safety alert calls attention to a situation that may arise with the CDI H/S Cuvette and recommends how to respond should the CDI Blood Parameter Monitoring System 500 display the error message "H/S disconnect at cuvette." this may occur when the CDI H/S Cuvette does not make a proper connection to the CDI H/S probe. In this situation, blood parameter values for HCT, Hgb, and SO2 do not display.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/custom-heart-lung-packs-2016-0

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