Tearaway Introducer Sets
Brand(s)
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
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