Product Wiki · Recalls · Health Canada — Medical Devices

HEATER-COOLER UNIT HCU40 (2021-08-25) — recall 62824

Health Canada — Medical Devices · Canada · 2021-09-10 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62824
Date of alert
2021-09-10
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Cleaning and/or descaling procedures for the internal water circuits can lead to crystalline deposits in the 3-way-valve promoting corrosion and malfunctions. In case of a malfunction of the 3-way valve, the valve does not close completely. In this case, a certain amount of warm water is not circulating in the main or patient circuit. Instead this warm water is guided back to the water tank leading to an increase of the water temperature and accelerated melting of the ice block. Consequently, the available time for the user to cool down the patient is reduced.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/heater-cooler-unit-hcu40-2021-

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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