FDA recall Z-2120-2019

Burlington Medical, LLC · Class II · device

Product

1 pc Full Wrap Back Relief Apron, Product Number B52 Front & Back Apron, Part Numbers SEB52*F, UEB52*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.

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.

Distribution

US Nationwide distribution. The products were distributed to the following foreign countries: Korea, Thailand.

Key facts

Status
Terminated
Initiation date
2019-06-07
Report date
2019-08-07
Termination date
2023-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Newport News, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2120-2019