Integra Cranial Kit
Brand(s)
Last updated
Summary
Product
Integra Cranial 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 Kit - No Drugs | 7275713 7289690 | INS-5HND |
Issue
The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect (potential holes and tears) in the sterile packaging (header bag) of the cranial access kit which creates a potential sterility concern. The header bag represents the sterile barrier for the cranial access kit, which is sold as a single use, sterile kit.
Recall start date: May 1, 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-75501
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