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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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
The recall is due to potential attenuation degradation over time. Degradation could reduce the apron's shielding effectiveness, potentially exposing patients to higher-than-expected radiation during procedures.
No injuries or incidents have been reported.
1. Stop using the product. 2. Follow recall instructions from Burlington Medical. 3. Contact Burlington Medical, LLC or your healthcare provider for instructions. 4. Monitor for manufacturer updates and potential replacement options.
Phone: Unknown. Website: Unknown. Hours: Unknown.
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