Health product recall

Karl Storz Hand Instruments

Last updated

Summary

Product
Karl Storz Hand Instruments
Issue
Medical devices - Sterility Issue
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 & 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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