FDAFDA · Food and drugs·Recall number Z-2128-2019
Hood, Product Number Hood, Part Numbers HOOD1, HOOD2 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.
Published August 7, 2019 · Recall initiated: June 7, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Burlington Medical, LLC
- Distributor
- US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.
- Lot
- Serial Numbers: 419558 419557 414132
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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