Health product recall

Karl Storz Se & Co. Kg Devices

Last updated

Summary

Product
Karl Storz Se & Co. Kg Devices
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
Flexible Digital Video Cystoscope More than 10 numbers, contact manufacturer. 11272VNU, 11272VN
Flexible Video Cystoscope Hd-View More than 10 numbers, contact manufacturer. 11272VH-TL, 11272VHU-TL
Broncho Fiberscope More than 10 numbers, contact manufacturer. 11005BC1
Ureteroscope More than 10 numbers, contact manufacturer. 11278AC1, 11278AC2, 11278ACU1
Flexible Video-Uretero-Renoscope Flex-Xc More than 10 numbers, contact manufacturer. 11278VSU, 11278VU, 11278V/VU, 11278VSA, 11278VSUA, 11278VSE, 11278VSUE, 11278VA, 11278VUA
Flexible Cystoscope More than 10 numbers, contact manufacturer. 11272VA, 11272VU, 11272C2, 11272VUE-R, 11272CU1, 11272C1, 11272V, 11272VUE, 11272VUA
Flexible Pediatric Cystoscope More than 10 numbers, contact manufacturer. 11274BCU1
Rhin0-Laryngo Fiberscope More than 10 numbers, contact manufacturer. 11001RD1
Flexible Uretero-Reno Fiberscope More than 10 numbers, contact manufacturer. 11278A2, 11278AU1

Issue

This recall notice describes a labelling update to correct the instructions for use for the flexible endoscopes identified to advise that high-level disinfection and, for specific models, liquid chemical sterilization, should not be used as methods of reprocessing. Customers that do not have access to an appropriate sterilization method recommended in the applicable instructions for use for these endoscopes should discontinue use of the endoscopes and return them to Karl Storz as described.

Recall start date: Apr 6, 2022

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
Companies

Karl Storz Se & Co. Kg

Dr.-Karl-Storz Strasse 34, Tuttlingen

Germany, 78532

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64075