Karl Storz Telescopes
Brand(s)
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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