🔍 RecallPedia

Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

Class I - Dangerous
🏥 Medical Devices Recalled: April 17, 2024 Integra LifeSciences Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025
  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:
Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise 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 (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

Product Codes/Lot Numbers:

UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1873-2024

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Class I - Dangerous

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