Health product recall

Karl Storz Injection Needles

Last updated

Summary

Product
Karl Storz Injection Needles
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Flexible Injection Needle All lots. 27182A
Injection Needle All lots. 26175 PD 810506 8598D
Laryngeal Injection Needle All lots. 8598B 8598A

Issue

Validation testing of the efficacy of the manual cleaning for the injection needle was performed. The testing showed that the required efficacy level was not achieved.  Different scenarios were tested, and all possible manual cleaning steps included, and the residual protein value remained above the acceptance criteria.

Recall start date: October 16, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - Obstetrics and gynaecology
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-74500