Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI: (01)00827002013773(17) Lot Number: 15786588
  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:
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Trocar Needle - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G01377

Product Codes/Lot Numbers:

UDI: (01)00827002013773(17) Lot Number: 15786588

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1526-2024

Related Recalls

Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.

May 15, 2025 Diagnostic Equipment View Details →