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Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476

Class I - Dangerous
🏥 Medical Devices Recalled: August 16, 2022 Cook Incorporated Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    THSCF-25-180-3 G02165 UDI-DI: 00827002021655 Lots/Expiration Dates: 14797761 16-06-2027 14813704 27-06-2027 TSCF-25-80-3 G00476 UDI-DI: 00827002004764 Lots/Expiration Dates: NS14797766 16-06-2027 NS14807600 22-06-2027 NS14821727 30-06-2027
  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 Incorporated
Reason for Recall:
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476

Product Codes/Lot Numbers:

THSCF-25-180-3 G02165 UDI-DI: 00827002021655 Lots/Expiration Dates: 14797761 16-06-2027 14813704 27-06-2027 TSCF-25-80-3 G00476 UDI-DI: 00827002004764 Lots/Expiration Dates: NS14797766 16-06-2027 NS14807600 22-06-2027 NS14821727 30-06-2027

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1832-2022

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