Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All lots (UDI): 05055270913678
  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:
Rocket Medical Plc
Reason for Recall:
A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Rocket KCH Fetal Bladder Drainage Catheter Model: R57405

Product Codes/Lot Numbers:

All lots (UDI): 05055270913678

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0512-2020