🔍 RecallPedia

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

Class I - Dangerous
🏥 Medical Devices Recalled: March 17, 2021 Integra LifeSciences Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205
  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:
Incorrect labeling, Catheter did not have the required holes and markings
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524

Product Codes/Lot Numbers:

Lot Number: 5028205 UDI: (01)10381780526797 (17)210930(10)5028205

Distribution:

Distributed in: CA, CO, FL, KY, MD, NC, NY, TX, WI

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1354-2021

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Integra LifeSciences

Class I - Dangerous

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