Karl Storz Hand Instruments
Brand(s)
Last updated
Summary
Product
Karl Storz Hand Instruments
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 catalog number |
|---|---|---|
| Sphenoid Punch, 30°, 11 Cm | All lots. | 615025 |
| Beyer Antrum Punch | All lots. | 615000 |
| Optical Biopsy And Grasping Forceps | All lots. | 723400 |
| Working Insert, With Steering Lever | All lots. | 26161UH |
| Sphenoid Punch, 3.2 X 4 Mm | All lots. | 648500 |
| Sphenoid Punch, 30°, 1.6 X 2 Mm | All lots. | 648523 |
| Uvula Retractor | All lots. | 723014 |
| Optical Scissor | All lots. | 11540OS |
| Antrum Punch, 65°, 11 Cm | All lots. | 615010 |
| Galea Spring Hook, 31 Cm | All lots. | 662797 |
| Grasping Forceps, Flexible, 1 Mm | All lots. | 11003MB |
Issue
It was found that there is insufficient evidence to show that the reprocessing method of the products was adequately validated. This issue affects all lot numbers of the referenced Karl Storz article numbers.
Recall Start Date: December 22, 2023
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Ear, nose and throat
Health products - Medical devices - Gastroenterology and urology
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - Obstetrics and gynaecology
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-74884
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