🔍 RecallPedia

Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S

Class I - Dangerous
🏥 Medical Devices Recalled: July 19, 2019 Integra LifeSciences Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Lot # J2670Y
  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:
Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S

Product Codes/Lot Numbers:

Lot # J2670Y

Distribution:

Distributed in: KY, NJ, RI, TX, WA, BE

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2206-2019

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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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