🔍 RecallPedia

PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

Class I - Dangerous
🏥 Medical Devices Recalled: January 4, 2019 Cook Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    7832498 7832499 7832500 7925385 7925387 7930517 8090868 8287793 8287794 8287799 8400121 8548813 8548815 NS8548814 7760235 7881599 8062433 8074027 8290383 8290384 8404559 8404562 7999663 8077582 8077583 8065959 8073949 8074014 8074015
  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:
Cook Inc.
Reason for Recall:
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10

Product Codes/Lot Numbers:

7832498 7832499 7832500 7925385 7925387 7930517 8090868 8287793 8287794 8287799 8400121 8548813 8548815 NS8548814 7760235 7881599 8062433 8074027 8290383 8290384 8404559 8404562 7999663 8077582 8077583 8065959 8073949 8074014 8074015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0962-2020

Related Recalls