🔍 RecallPedia

Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678

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:
    TCMTNA-35-145-3 G01678 UDI-DI: 00827002016781 Lots/Expiration Dates: 14808819 22-06-2027 NS14821223 30-06-2027 NS14851713 21-07-2027
  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:

Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part Number/GPN TCMTNA-35-145-3 G01678

Product Codes/Lot Numbers:

TCMTNA-35-145-3 G01678 UDI-DI: 00827002016781 Lots/Expiration Dates: 14808819 22-06-2027 NS14821223 30-06-2027 NS14851713 21-07-2027

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1846-2022

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