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Cranial access kit

Official notice

27 Nov 2023

Last checked

27 Nov 2023

Medium riskHealth Canada

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. 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 Published 2023-11-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

74655

Official notice

2023-11-27

The hazard

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

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

74655

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Affected products

Product 1

Affected products - Cranial Access Kit, Lot or serial number - 6896403 7248999 7073042 6788611 6710219 6788610 7249000, Model or catalogue number - INS-5HND

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Integra Pain Management, Cranial Access Kit.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

74655

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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