🔍 RecallPedia

Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490

Class I - Dangerous
🏥 Medical Devices Recalled: March 1, 2024 Cook Incorporated Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532
  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:

Peel-Away Introducer - Intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for nonvascular use. REFERENCE PART NUMBER (RPN)/ ORDER NUMBER (GPN): 1)PLVW-7.0-35 G00925 2)PLVW-8.0-35 G01844 : DTVN-5.0-19-10.0- YUEH : G09490

Product Codes/Lot Numbers:

UDI-DI/Lot Number: 1) (01)00827002009257(17) 15777767 2) (01)00827002018440(17) NS15787532

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1528-2024

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 →