Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

Class I - Dangerous

🏥 Medical Devices Recalled: January 19, 2024 Integra LifeSciences Other Medical Devices Nationwide

What Should You Do?

Check if you have this product:
UDI: 10381780263975 Lot Number Exp: Date: 6710227 30-Jun-24 6788602 30-Jun-24 6955170 7-Feb-25 7000268 7-Feb-05 7028247 10-Apr-25 7078234 11-May-25 7249010 18-Jul-25 7253163 22-Jun-25
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Integra LifeSciences Corp.
Reason for Recall:: A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

Ref No: INSHITHND / Integra¿ Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the lateral ventricles of the brain.

Product Codes/Lot Numbers:

UDI: 10381780263975 Lot Number Exp: Date: 6710227 30-Jun-24 6788602 30-Jun-24 6955170 7-Feb-25 7000268 7-Feb-05 7028247 10-Apr-25 7078234 11-May-25 7249010 18-Jul-25 7253163 22-Jun-25