🔍 RecallPedia

Ref No: INSHITHRZN / Integra Cranial Access Kit. 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?

  1. Check if you have this product:
    UDI: 10381780263982 Lot Number Exp: Date: 6631607 1-Sep-23 6631608 1-Dec-23 6710216 1-Sep-23 6710217 1-Dec-23 6788605 1-Jan-24 6788606 1-Jan-24 6896388 17-Mar-24 6896389 1-Dec-23 6955158 17-Mar-24 6955159 17-Mar-24 7000265 17-Mar-24 7000266 17-Mar-24 7028235 17-Mar-24 7073054 17-Mar-24 7073055 1-Apr-24 7124709 1-Apr-24 7124710 1-Apr-24 7249011 1-Apr-24 7253162 1-Jun-24 7257042 1-Jun-24 7257043 1-Jun-24 7264841 1-Jun-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:
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: INSHITHRZN / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Product Codes/Lot Numbers:

UDI: 10381780263982 Lot Number Exp: Date: 6631607 1-Sep-23 6631608 1-Dec-23 6710216 1-Sep-23 6710217 1-Dec-23 6788605 1-Jan-24 6788606 1-Jan-24 6896388 17-Mar-24 6896389 1-Dec-23 6955158 17-Mar-24 6955159 17-Mar-24 7000265 17-Mar-24 7000266 17-Mar-24 7028235 17-Mar-24 7073054 17-Mar-24 7073055 1-Apr-24 7124709 1-Apr-24 7124710 1-Apr-24 7249011 1-Apr-24 7253162 1-Jun-24 7257042 1-Jun-24 7257043 1-Jun-24 7264841 1-Jun-24

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1203-2024

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