Public recall detail

Cranial Access Kit

2023-11-27

medium
Recall Safety notice
Quick summary

Quick summary: Cranial Access Kit. Date: 2023-11-27.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Cranial Access Kit. Date: 2023-11-27.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandIntegra Pain Management
ProductCranial Access Kit
IssueMedical devices - Labelling and packaging Medical devices - Sterility
Recall classType II
IdentificationRA-74655

Affected products

ProductCranial Access Kit
Lot6896403 7248999 7073042 6788611 6710219 6788610 7249000
ModelINS-5HND
Serial number6896403 7248999 7073042 6788611 6710219 6788610 7249000
DescriptionCranial Access Kit

Issue

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesIntegra Pain Management 3498 West 2400 South #1050, West Valley City, Utah, United States, 84119
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74655
Background{}
CompaniesIntegra Pain Management 3498 West 2400 South #1050, West Valley City, Utah, United States, 84119
AudiencesHealthcare
Source updated2023-11-27

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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