Health product recall

Tearaway Introducer Sets

Last updated

Summary

Product
Tearaway Introducer Sets
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Industry

Affected products

Affected products Lot or serial number Model or catalog number
Tearaway Introducer Sets 21148681 INT-106-09

Issue

Potential of the luer connection portion of the dilator hub to crack or dislodge during use on certain tearaway sheath introducer assemblies. The potential for the luer connection of the dilator hub to crack or dislodge is due to improper storage conditions of the dilator component and has occurred in only a small percentage of the tearaway introducer product.

Recall start date: May 8, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Galt Medical Corporation

2220 Merritt Drive, Garland, Texas, United States, 75041

Published by
Health Canada
Audience
Industry
Recall class
Type II
Identification number
RA-73952