Product Wiki · Recalls · Health Canada — Medical Devices

Leisegang and Frigitronics Cryosurgery System (2015-11-12) — recall 54547

Health Canada — Medical Devices · Canada · 2015-11-12 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
54547
Date of alert
2015-11-12
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: CooperSurgical is advising all Leisegang LM-900 Cryosugery System users that there are questions regarding the validity of the current high level disinfection procedure for the shaft of the system's hand piece. This notification does not include any cryosurgical tips which currently have a validated high level disinfection procedure. Therefore, CooperSurgical is advising all customers of record to practice all necessary diligence when using the device.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/leisegang-and-frigitronics-cry

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