Recall MonitorHealth Products
Gyrus ACMI® Classic Series Continuous Flow Resectoscope
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
Product: Gyrus ACMI® Classic Series Continuous Flow Resectoscope
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 |
|---|---|---|
| Classic Series Continuous Flow Resectoscope | More than 10 numbers, contact manufacturer. | 188A |
| Classic Series Continuous Flow Resectoscope | More than 10 numbers, contact manufacturer. | 188 |
| Classic Series Continuous Flow Resectoscope | More than 10 numbers, contact manufacturer. | 194 |
Issue
This recall action is being taken because it has been determined that some of the sets of sterilization parameters provided in the IFU may not consistently render the devices adequately sterile.