Health product recall

Cranial Access Kit

Last updated

Summary

Product
Cranial Access Kit
Issue
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 catalog number
Cranial Access Kit 7249001 7253133 7253134 INS-5HND

Issue

Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits causing the packaging to fail the required packaging integrity testing criteria. Therefore, there is a potential sterility concern for any lots produced with this outer packaging.  The outer packaging represents the sterile barrier for the cranial access kits, which are sold as single use, sterile kits.

Recall start date: January 31, 2024

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-75061