FDAFDA · Food and drugs·Recall number Z-2113-2019
Vest, Single Item, Product Number Vest, Part Numbers ECREVESTD, ECREVESTF, ECREVESTXLF, REVEST*M, REVESTB, REVESTC, SEVEST*F, SEVEST*M, SEVESTA, SEVESTB, SEVESTC, UEVESTB, UEVESTXLM 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: 382976 382964 385618 391130 391143 382858 381860 385617 381858 381854 387903 391141 442855 381789 387954 382861 391150 387944 387965 419791 385623 414166
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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