Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Box part number CPPS-MN-1820; Multipack part number CPPS-MN-1820-5; UDI: (01)00813787021515(10)18090480(11)180904(17)220831; Lot # 180904-80
  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:
Theragenics Corporation
Reason for Recall:
Some of the pouches containing Brachytherapy Applicator Needles (18g x 20cm) were not sealed
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Theragenics Applicator Needle (18g x 20cm) The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle.

Product Codes/Lot Numbers:

Box part number CPPS-MN-1820; Multipack part number CPPS-MN-1820-5; UDI: (01)00813787021515(10)18090480(11)180904(17)220831; Lot # 180904-80

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0643-2019