Recall MonitorHealth Products
Olympus Medical Single Use Electrosurgical Snare SD-400
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Olympus Medical Single Use Electrosurgical Snare SD-400
Issue: Medical devices - Sterility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Single Use Electrosurgical Snare SD-400 | More than 10 numbers, contact manufacturer. | SD-400U-15 |
| Single Use Electrosurgical Snare SD-400 | More than 10 numbers, contact manufacturer. | SD-400U-10 |
Issue
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.