Health product recall

Gyrus ACMI® Classic Series Continuous Flow Resectoscope

Brand(s)
Last updated

Summary

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

Affected 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. 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies

Gyrus Acmi, Inc

9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Recall date
Identification number
RA-82241

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