Product Wiki · Recalls · Health Canada — Medical Devices

GentleCool Pro Cryogen Canister (2019-09-09) — recall 59648

Health Canada — Medical Devices · Canada · 2019-10-11 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
59648
Date of alert
2019-10-11
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: The issue observed in the field and documented in Candela's associated complaints details that the neck bushing (or top) of the canister becoming disconnected from the body of the canister, causing rapid depressurization. This event can injure the patient/operator by a) uncontrolled cryogen gas spray and b) propelling the gas canister away from the system in an uncontrolled manner with significant velocity. Please refer to the attached health hazard evaluation for a complete description.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/gentlecool-pro-cryogen-caniste

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