Burlington Medical recalled 402 Half Aprons sold worldwide after potential attenuation degradation. Attenuation material Xenolite 800 may degrade over time, reducing shielding lifespan. Patients and healthcare providers should stop using the aprons immediately and contact Burlington Medical for recall instructions.
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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Radiation shielding half aprons are used during radiology procedures to protect patients from scatter radiation.
Attenuation material degradation over time could reduce shielding effectiveness and lifespan, potentially increasing radiation exposure risk.
This recall is not part of a broader industry pattern.
With 402 units distributed worldwide, patients and healthcare providers face potential exposure risk if shielding degrades. Immediate cessation of use is advised until remedies are provided.
UDI-DI on product label, packaging, or documentation; recall notice provides model list.
4-8 weeks for refund or replacement processing once a remedy is issued by Burlington Medical.
Keep recall letter, model numbers, UDI-DI codes, and all correspondence. Photograph the labels and packaging for records.
Model numbers affected include R8HALF1B, R8HALF1H, R8HALF2B, R8HALF2H, R8HALF3B, R8HALF3H, R8HALF4B, R8HALF4H, R8HALF5B, R8HALF5H, R8HALF6B, R8HALF6H, R8HALFSETB, R8HALFSETH, S8HALF1H, S8HALF2B, S8HALF2H, S8HALF3B, S8HALF3H, S8HALF4B. UDI-DI codes corresponding to each model are provided in the recall notice. Manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. Quantity: 402 units. Distribution: Worldwide with US distribution and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand,Taiw
No injuries or incidents have been reported.
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