FIVE S 3.5X65, STERILE FOR SINGLE USE
Brand(s)
Last updated
Summary
Product
FIVE S 3.5X65, STERILE FOR SINGLE USE
Issue
Medical devices - Lack of efficacy
What to do
Contact the manufacturer if you require additional information
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
FIVE S 3.5X65, STERILE FOR SINGLE USE |
More than 10 numbers, contact manufacturer. |
091361-01 |
Issue
|
For products affected, the required sterility assurance level was not achieved during recent testing of the sterilization process performed by the contract sterilizer. The testing was initiated as a result of a regular re-qualification review. The affected products therefore may not be "sterile" as claimed. Recall start date: 2021-08-09 |
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies
KARL STORZ ENDOSCOPY CANADA LTD
7171 MILLCREEK DRIVE, MISSISSAUGA
ON, CANADA
L5N 3R3
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63610
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