CanadaOlympus Medical Single Use Electrosurgical Snare SD-400 (models SD-400U-15 and SD-400U-10) is affected; affected lots are identified by lot or serial numbers consisting of more than 10 numbers—contact the manufacturer to confirm. The recall was issued because small holes may occur during packaging into the shelf carton and/or during transportation, creating a potential sterility breach, and users should cease use of the affected lots immediately; contact the manufacturer for additional information.
What's being recalled
Companies: Olympus Medical Systems Corp., 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507.
How to identify it
Affected products: Single Use Electrosurgical Snare SD-400; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SD-400U-15
Affected products: Single Use Electrosurgical Snare SD-400; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: SD-400U-10
The hazard
Olympus's investigation determined that small holes may occur during packaging of SD-400 device pouches into the shelf carton and/or during transportation of the shelf carton. Users should cease usage of the affected lots immediately due to the potential sterility breach.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)