🔍 RecallPedia

Cap, Product Number Cap, Part Numbers CAP1, CAP2 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: 389083 423885 413884 417509 384253 378507 378503 378505 418959 418960 423897 423899 423893 423895 414395 419567 417515 417514 420508 385648 414155 420509 415418 420507 420501 409316 409320 409330 403879 403880 403882 403881 409310 404000 441028 441030 441022 441031 441027 442251 443572 441025 441024 443579 443574 431256 443575 431517 443573
  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:

Cap, Product Number Cap, Part Numbers CAP1, CAP2 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: 389083 423885 413884 417509 384253 378507 378503 378505 418959 418960 423897 423899 423893 423895 414395 419567 417515 417514 420508 385648 414155 420509 415418 420507 420501 409316 409320 409330 403879 403880 403882 403881 409310 404000 441028 441030 441022 441031 441027 442251 443572 441025 441024 443579 443574 431256 443575 431517 443573

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2127-2019

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