Recall MonitorHealth Products
CleverCut and FlowCut Sphincterotomes
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology, Health products - Medical devices - General and plastic surgery
Product: CleverCut and FlowCut Sphincterotomes
Issue: Medical devices - Performance
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 |
|---|---|---|
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0725 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V431M-0720 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-411Q-0730 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V431M-0730 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0320 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0730 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0330 |
| Disposable Triple Lumen Sphincterotome | More than 10 numbers, contact manufacturer. | KD-V411M-0720 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC411Q-0320 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC411Q-0720 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC433Q-0730 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC412Q-0215 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC431Q-0720 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC411Q-0330 |
| Sphincterotome | More than 10 numbers, contact manufacturer. | KD-VC433Q-0720 |
Issue
CleverCut and FlowCut sphincterotome devices which did not undergo thermoforming could deform and lose performance. Olympus is removing lots where the devices may not have been manufactured with the thermoforming process. Users are to cease usage and contact customer service to return their affected product.