Cranial Access Kit
Brand(s)
Last updated
Summary
Product
Cranial Access Kit
Issue
Medical devices - Sterility
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
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