8694 - Laser Application Instrument, 23 Cm
Brand(s)
Last updated
Summary
Product
8694 - Laser Application Instrument, 23 Cm
Issue
Medical devices - Performance 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 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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