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Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108

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:
    NS8070854 8078209 8116743
  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:

Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108

Product Codes/Lot Numbers:

NS8070854 8078209 8116743

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0968-2020

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