Health product recall

8694 - Laser Application Instrument, 23 Cm

Last updated

Summary

Product
8694 - Laser Application Instrument, 23 Cm
Issue
Medical devices - Performance
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 catalogue number

8694 - Laser Application Instrument, 23 Cm

All lots.

461000

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. During the update of the technical documentation, it was determined that there is insufficient evidence of the validation of the reprocessing methods; therefore, the affected products are being recalled.

Recall start date: March 1, 2024

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-75810

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