CanadaThe affected product is the Gyrus ACMI Classic Series Continuous Flow Resectoscope (model/catalogue numbers 188, 188A and 194), identifiable by lot or serial numbers of more than 10 numbers — contact the manufacturer for specific identifiers. It was recalled because some sterilization parameter sets in the Instructions for Use may not consistently render the devices adequately sterile; contact the manufacturer if you require additional information.
What's being recalled
Companies: Gyrus Acmi, Inc, 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445.
How to identify it
Affected products: Classic Series Continuous Flow Resectoscope; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 188A
Affected products: Classic Series Continuous Flow Resectoscope; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 188
Affected products: Classic Series Continuous Flow Resectoscope; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 194
The hazard
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.
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)