The Recall Desk
HighFDA (Devices)·Z-2107-2019·Announced 2019-08-07

Burlington Medical Recalls Frontal Stretch Buckle Closure Aprons

Burlington Medical is recalling nine Frontal Stretch Buckle Closure Aprons 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 (radiation protection) where the hazard is theoretical (potential inadequate protection) and no injuries or illnesses have been reported in the source text.

Plain-English summary

Burlington Medical, LLC is recalling nine units of the Frontal Stretch Buckle Closure Apron, Product Number A-10. The affected part numbers are REA10A, REA10B, REA10C, REA10*F, REA10*M, and UEA10*M. These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures.

The recall was initiated because the protective material used in the manufacture of these aprons could potentially provide inadequate protection for the user. Using these 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.

The products were distributed nationwide in the United States and to Korea and Thailand. The specific serial numbers for the recalled units are 423604, 423524, 423537, 423549, 387906, 423539, 423577, 444669, and 384383. Healthcare workers and facilities should check their inventory for these specific serial numbers and stop using the affected aprons.

The recalled product

Product
Frontal Stretch Buckle Closure Apron, Product Number A-10, Part Numbers REA10A, REA10B, REA10C, REA10*F, REA10*M, UEA10*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic pr
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
9

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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