Cranial Access Kit
Brand(s)
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 |
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
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