Public recall detail

Integra Cranial Kit

2024-05-08

medium
Recall Safety notice
Quick summary

Quick summary: Integra Cranial Kit. Date: 2024-05-08.

Recommended action

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

Recall details

Quick summary: Integra Cranial Kit. Date: 2024-05-08.

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
ProductIntegra Cranial Kit
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-75501

Affected products

ProductCranial Kit - No Drugs
Lot7275713 7289690
ModelINS-5HND
Serial number7275713 7289690
DescriptionCranial Kit - No Drugs

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

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-75501
Background{}
CompaniesIntegra Pain Management 3498 West 2400 South #1050, West Valley City, Utah, United States, 84119
AudiencesHealthcare
Source updated2024-05-08

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

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