Product Wiki · Recalls · Health Canada — Medical Devices

Terumo Cardiovascular Procedure Kits — recall 75310

Health Canada — Medical Devices · Canada · 2024-03-28 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
75310
Date of alert
2024-03-28
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Cardiovascular
Product type
Medical devices
Reported risk: CHS initiated this recall after receiving a notification from Terumo on their cardiovascular procedure kits that include high crack check valve. Terumo cardiovascular systems (Terumo CVS) has received six complaints whereby the pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmhg versus 400mmhg. Recall start date: February 26, 2024
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/terumo-cardiovascular-procedur

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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