Product Wiki · Recalls · Health Canada — Medical Devices

SPIROS CLOSED MALE LUER (2021-03-12) — recall 62875

Health Canada — Medical Devices · Canada · 2021-10-01 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62875
Date of alert
2021-10-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: ICU medical has identified the potential for certain lots of spiros to exhibit small amounts of leaks due to a molding defect. The leak occurs when the spiros is not activated and prior to connecting to a patient's intravenous administration set. This issue pertains to both spinning and non-spinning spiros and was discovered through internal testing.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/spiros-closed-male-luer-2021-0

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