Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00840663101580, 00840663101559, 00840663101566, 00840663101597, 00840663101573, 00840663101603. Catalog Numbers: 2102-09, E2102-09. Lot not expired with the following prefix: PIO, QPI, XPI.
  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:
LeMaitre Vascular, Inc.
Reason for Recall:
During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier).
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Pruitt Irrigation Occlusion Catheter. Catalog Numbers: 2102-09, E2102-09.

Product Codes/Lot Numbers:

UDI-DI: 00840663101580, 00840663101559, 00840663101566, 00840663101597, 00840663101573, 00840663101603. Catalog Numbers: 2102-09, E2102-09. Lot not expired with the following prefix: PIO, QPI, XPI.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1752-2025

Related Recalls

Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.

Aug 25, 2025 Other Medical Devices View Details β†’