Health product recall

Cranial Access Kit

Last updated

Summary

Product
Cranial Access Kit
Issue
Medical devices - Labelling and packaging
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
Cranial Access Kit 6896403 7248999 7073042 6788611 6710219 6788610 7249000 INS-5HND

Issue

Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits. This defect can cause the packaging to split without any additional forces outside of regular manufacturing and sterilization/shipping forces being applied.  The outer packaging represents the sterile barrier for the cranial access kits, which are sold as single use, sterile kits.

Recall start date: November 9, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Neurology
Companies
Integra Pain Management
3498 West 2400 South #1050, West Valley City, Utah, United States, 84119
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74655