🔍 RecallPedia

Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

Class I - Dangerous
🏥 Medical Devices Recalled: April 1, 2021 CLINICAL LASERTHERMIA SYSTEMS AB Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot ID: 116540030718, 116540201117
  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:
CLINICAL LASERTHERMIA SYSTEMS AB
Reason for Recall:
single use devices labeled as sterile may not have been adequately sterilized
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Tranberg MR Stylet, 1.8mm/15G, 230mm, REF: 4013-06, Rx Only, Sterile EO - Product Usage: used with the Tranberg¿ MR Introducer; a device used to aid the insertion of the Laser Applicator into the tissue.

Product Codes/Lot Numbers:

Lot ID: 116540030718, 116540201117

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1781-2021

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