🔍 RecallPedia

Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M 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: 387197 384398 387814 418788 419871 387879 385725 385749 385732 387887 382947 419840 418873 423988 385738 387937 444696 418901 381799 419884 379705 386112 416433 415529 443261 418973 419967 419814 423980 419787 419892 391089 391128 385744 379537 417552 414129
  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:

Kilt, Single Item, Product Number Kilt, Part Numbers ECREKILTF, ECREKILTXLF, REKILTA, REKILTB, REKILTXLF, REKILTXLM, REKILT*M, SEKILTB, SEKILTC, SEKILT*F, SEKILT*M 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: 387197 384398 387814 418788 419871 387879 385725 385749 385732 387887 382947 419840 418873 423988 385738 387937 444696 418901 381799 419884 379705 386112 416433 415529 443261 418973 419967 419814 423980 419787 419892 391089 391128 385744 379537 417552 414129

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2118-2019

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