🔍 RecallPedia

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Class I - Dangerous
🏥 Medical Devices Recalled: December 15, 2022 Stradis Healthcare Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466
  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:
Stradis Healthcare
Reason for Recall:
Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Product Codes/Lot Numbers:

a. Assembly Number 33066, UDI-DI: M752330661, Lot Numbers: 222782334, 222519530, 222438660; b. Assembly Number 33068, UDI-DI: M752330681, Lot Numbers: 222145412, 220551558, 222508466

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0931-2023

Related Recalls