Burlington Medical recalled 14,323 Frontal Aprons sold worldwide after regulators flagged attenuation degradation over time. The aprons use Xenolite 800 shielding material. Healthcare providers should stop using the devices immediately and await instructions from Burlington Medical.
Potential for attenuation degradation over time, decreasing the lifespan.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Burlington Medical, LLC or your healthcare provider for instructions. Notification method: Letter
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Frontal aprons are radiation-shielding garments worn by healthcare workers during X-ray procedures to protect vital organs.
Over time, the Xenolite 800 attenuation material may degrade, reducing shielding effectiveness and potentially increasing radiation exposure risk.
This recall is not described as part of a broader industry pattern in the provided data.
Hospitals and clinics may need to halt use of affected aprons and coordinate replacements, potentially impacting workflow and safety budgets.
UDI-DI labels, product tags, and device documentation.
Remedy details will be issued by Burlington Medical; expect replacement or repair guidance to follow recall notices.
Keep a record of the recall notice, model numbers, date codes, correspondence with the manufacturer, and any replacement shipments.
Model numbers include C8F17 and the R8601 family, with multiple UDI-DI codes listed. Distributed worldwide, including US nationwide and international markets (Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, Vietnam). Manufactured with Xenolite 800 attenuation material from 2025-01-16 to 2026-01-21. Quantity: 14,323 units. Sold through worldwide distribution to healthcare facilities.
No injuries or incidents have been reported.
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