Product Wiki · Recalls · Health Canada — Medical Devices

SARNS Modular Perfusion System 8000 — recall 56685

Health Canada — Medical Devices · Canada · 2017-03-31 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56685
Date of alert
2017-03-31
Country / jurisdiction
Canada
Authority classification
Type III
Notice type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Terumo Cardiovascular Systems (Terumo CVS) has determined that level sensor II pads product labels have the expiration date displayed in a format that may not be recognizable to all users. These products are used with Terumo Advanced Perfusion System 1 and SARNS Modular Perfusion System 8000 heart-lung machines. The issue was identified via internal investigation, and there have been no related user complaints. Terumo CVS is providing directions on how to read the expiration date on affected products.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/sarns-modular-perfusion-system

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