🔍 RecallPedia

Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230

Class I - Dangerous
🏥 Medical Devices Recalled: May 15, 2024 Cook Incorporated Surgical Instruments

What Should You Do?

  1. Check if you have this product:
    UDI: (01)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530
  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:
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter ULT16.0-38-25-P-6S-MCL-HC--Intended for percutaneous drainage in a variety of drainage applications (e.g., nephrostomy, biliary and abscess), either by direct stick or Seldinger access technique. ORDER NUMBER: GPN: G09230

Product Codes/Lot Numbers:

UDI: (01)00827002092303(17)270228(10)NS15924530 Lot Number: NS15924530

Distribution:

Distributed in: MA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2222-2024

Related Recalls

Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic and therapeutic procedures. Catheters are available in various configurations. Configurations include different shaft lengths and tip curves and some catheters are manufactured with a hydrophilic coating. Refer to the product label for product specifications (e.g., catheter length, distal curve configuration).

Cook Incorporated

Class I - Dangerous

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

May 15, 2025 Diagnostic Equipment View Details →