The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2124-2019·Announced 2019-08-07

Burlington Medical Recalls Frontal Radiation Protection Aprons Due to Inadequate Shielding

Burlington Medical is recalling Frontal Aprons with Quick Drop Velcro Closure 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 (radiation exposure) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Burlington Medical, LLC is recalling Frontal Aprons with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M. These products are designed to protect healthcare workers against scatter (secondary) radiation during fluoroscopic and radiographic procedures.

The recall is issued because the protective material used in the manufacture of the 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.

The products were distributed US Nationwide and to Korea and Thailand. The specific serial number identified in the recall is 418937. Healthcare workers and facilities should stop using the affected aprons and contact Burlington Medical for instructions on return or replacement.

The recalled product

Product
Frontal Apron with Quick Drop Velcro Closure (no elastic), Product Number 401, Part Numbers RE401*M Product Usage: Products are designed to protect healthcare workers against scatter (secondary) radiation while performing fluoroscopic and radiographic procedures by reducing…
Manufacturer
Burlington Medical, LLC
Category
Medical Device — Radiation Protection
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial Numbers: 418937

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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