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Cranial access kit
Official notice
9 Feb 2024
Last checked
9 Feb 2024
An official Health Canada notice concerns Cranial access kit. 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 Published 2024-02-09.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75061
Official notice
2024-02-09
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Integra Pain Management, Cranial Access Kit.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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