The Recall Desk
HighFDA (Devices)·Z-2116-2019·Announced 2019-08-07

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.

What this means for you

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 fl
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
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.

See all 24 products in this recall →

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