Health product recall

Five S 5.3

Last updated

Summary

Product
Five S 5.3
Issue
Medical devices - Sterility
What to do

Review notice & share with users, quarantine/ discontinue use of remaining inventory, return reply form. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalogue number
Five S 5.3 All lots. 0915612-06

Issue

Due to a failed revalidation of the sterilization process, there is no proof of the sterility of the products. The hazardous situation, that a contaminated product is used could lead to the consequence of patient infection.

There is no subsequent risk to user or third parties.

Recall start date: August 1, 2023
 

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Companies
Karl Storz Se & Co. Kg
Dr.-Karl-Storz Strasse 34, Tuttlingen, Germany, 78532
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74136

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