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Integra cranial kit
Official notice
8 May 2024
Last checked
8 May 2024
An official Health Canada notice concerns Integra cranial kit. 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 Published 2024-05-08.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75501
Official notice
2024-05-08
The hazard
The hazard
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
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, Integra Cranial 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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