🔍 RecallPedia

Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F 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: 381839 382008 381834 423928 423922 423917 423919 423921 423916 387073 423925 387072 423918 419789 387168 423923 423926 423924 387116 391152 381819 381824 391111 391093 387078 381786 382901 419907 419906 403296 382883 387075 391159 382894 391166 418938 387975 418911 382881 403349 405569 443366 377104 423704 403406 419550 419902 419903
  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:

Front/Back Apron with Stretch Velcro Closure, Product Number EURO, Part Numbers ECSEEUROA, ECSEEUROB, ECSEEUROC, ECSEEUROXLM, REEURO*F, REEURO*M, REEUROC, REEUROE, SEEURO*F, SEEURO*M, UEEURO*F 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: 381839 382008 381834 423928 423922 423917 423919 423921 423916 387073 423925 387072 423918 419789 387168 423923 423926 423924 387116 391152 381819 381824 391111 391093 387078 381786 382901 419907 419906 403296 382883 387075 391159 382894 391166 418938 387975 418911 382881 403349 405569 443366 377104 423704 403406 419550 419902 419903

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2125-2019

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