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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