🔍 RecallPedia

Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves

Class I - Dangerous
🏥 Medical Devices Recalled: August 23, 2016 Integra LifeSciences Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog Number VC-1, Lot #0195451 with expiry 05/2019
  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:
During final sampling inspection, one of the lots was discovered with a total incomplete packaging seal of the sterile product.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Integra Straight Ventricular Catheter F8, 25 cm, Sterile EO, Rx only, packaged in a Tyvek pouch and secondary packaged in to Tyvek pouch, sealed in a cardboard box. Silicone elastomer Ventricular Catheter for use with hydrocephalus valves

Product Codes/Lot Numbers:

Catalog Number VC-1, Lot #0195451 with expiry 05/2019

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2905-2016

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Integra LifeSciences

Class I - Dangerous

Potential that the induction seal is not completely sealed to the device tube packaging.

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