🔍 RecallPedia

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04

Class I - Dangerous
🏥 Medical Devices Recalled: October 19, 2023 Integra LifeSciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 10381780263869 Lot Number/Exp. Date: 6788615 1-Dec-23; 7002983 1-Jan-24
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. 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:
Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Integra Cranial Access Kit-For access to the subarachnoid space or the lateral ventricles of the brain. Catalog Number: HITHSP04

Product Codes/Lot Numbers:

UDI-DI: 10381780263869 Lot Number/Exp. Date: 6788615 1-Dec-23; 7002983 1-Jan-24

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0498-2024

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Integra LifeSciences

Class I - Dangerous

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