Health product recall

FIVE S 3.5X65, STERILE FOR SINGLE USE

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
091361-06

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: 2021-11-19
Alert / recall type
Health product recall
Category
Health product - Medical device - 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