Five S 5.3
Brand(s)
Last updated
Summary
Product
Five S 5.3
Issue
Medical devices - Sterility Issue
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: 2023-08-16
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