Health product recall

Karl Storz Telescopes

Last updated

Summary

Product
Karl Storz Telescopes
Issue
Medical devices - Labelling and packaging
Medical devices - Sterility
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected prodcuts Lot or serial number Model or catalogue number
Telescopes All lots. 27830KA 27840KA
Hopkins Telescope All lots. 27093AA 27292AMA 27293AA 27092AMA
Nephro/Chold, Berci Telescope All lots. 27295AA 27294AA

Issue

The IFUs for the devices identifiers previously included cleaning methods other than manual cleaning and pre-vacuum steam as the approved reprocessing modalities. The IFU was updated to only include these two methods moving forward; therefore, there is a risk that a reprocessing modality that is not currently cleared could be utilized for reprocessing these devices. 

Recall start date: July 25, 2024

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
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-75889

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