Product Wiki · Recalls · Health Canada — Medical Devices

Laparoscopic cholecystectomy pack TBRHSC-LF, General laparoscopy CDS… — recall 59377

Health Canada — Medical Devices · Canada · 2019-06-14 · Type III

As described by Health Canada — Medical Devices: Laparoscopic cholecystectomy pack TBRHSC-LF, General laparoscopy CDS, Major GYN laparoscopy CDS, GYNE major laparoscopy GRH-LF, Hepatobiliaire laparoscopie-LF, Major laparoscopic SJHC-LF, Ensemble thoraco-LF, Laparoscopy RVHS-LF, and Laparoscopie chi...

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Agency
Health Canada — Medical Devices
Recall identifier
59377
Date of alert
2019-06-14
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Medline is recalling custom procedure packs containing Medline anti-fog solution. Medline has issued this recall because the anti-fog solution may not defog properly due to degradation in the chemical properties. Although the device failure is visually apparent and easily recognizable to the user as fog will be present in the endoscopic/laparoscopic instrument, the visual field may not be clear and there is a potential for a delay in the procedure.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/laparoscopic-cholecystectomy-p

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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