Burlington Medical Recalls Lead Apron Products Due to Inadequate Radiation Protection
Burlington Medical is recalling 332 lead apron products because the protective material may provide inadequate protection against scatter radiation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, and the hazard involves potential long-term exposure to radiation which may increase the risk of cancer or infertility.
Plain-English summary
Burlington Medical, LLC is recalling 332 units of the 2 pc Full Wrap Vest & Kilt Back-Saver (Product Number PVK). The products were distributed nationwide in the United States and to Korea and Thailand. The recall involves specific serial numbers listed in the official FDA notice.
The recall was initiated because the protective material used in the manufacture of these products could potentially provide inadequate protection for the user. Use of the products could expose the user to scatter radiation of varying degrees depending on variables such as distance, shielding, position, time, and kV. Long-term exposure to scatter radiation may increase the risk of cancer, infertility, or other health-related conditions.
Healthcare workers who use these products for fluoroscopic and radiographic procedures are affected. Users should stop using the recalled products and contact Burlington Medical for further instructions.
The recalled product
- Product
- 2 pc Full Wrap Vest & Kilt Back-Saver , Product Number PVK, Part Numbers REPVK*F, REPVK*M, REPVKE, REPVKF, REPVKXLM, SEPVK*F, SEPVK*M, SEPVKE, UEPVK*F Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing…
- Manufacturer
- Burlington Medical, LLC
- Affected units
- 332
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Burlington Medical, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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