🔍 RecallPedia

Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

Class I - Dangerous
🏥 Medical Devices Recalled: June 7, 2019 Burlington Medical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: 383071 418435 384523 379009 441088 441042 404378 383337 407642 375480 383073 383072 383186 420487 441239 414699 414689 414685 414702 414741 414692 388017 383269
  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:
Burlington Medical, LLC
Reason for Recall:
The protective material used in the manufacture of the products could potentially provide inadequate protection for the product user. Use of the products could expose the user to scatter radiation of varying degrees depending on many different variables (e.g., distance, shielding, position, time, kV, etc.). Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Thyroid Collar Oversize, Product Number TS3, Part Numbers RBTS3-R, RETS3-R, RLTS3-R, RLTS3-SEP, RLTS3-T2T Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing the amount of radiation reaching the user.

Product Codes/Lot Numbers:

Serial Numbers: 383071 418435 384523 379009 441088 441042 404378 383337 407642 375480 383073 383072 383186 420487 441239 414699 414689 414685 414702 414741 414692 388017 383269

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2130-2019

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