Health product recall

Integra Cranial Kit

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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