Burlington Medical recalled 961 caps used in medical devices sold to healthcare providers worldwide. The caps may experience attenuation degradation over time, shortening device lifespan. Healthcare providers and patients should stop using the affected caps and follow 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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Burlington Medical caps are used in medical devices that require attenuation materials for shielding. They are distributed worldwide to healthcare providers.
Attenuation material may degrade over time, reducing the shielding lifespan and potentially affecting device performance.
This recall is not described as part of a broader industry pattern.
The recall could disrupt medical workflows if devices in use require replacement or servicing. No injuries reported to date.
Serial numbers and UDIs are on the device labeling and packaging.
4-8 weeks for recall processing and replacement or disposition.
Keep the recall notice, model numbers, UDIs, and all correspondence. Photograph labels and packaging for records.
Quantity: 961 units. Distribution: Worldwide. Models: R8CAP, S8CAP, U8CAP. UDI-DI codes: 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD); 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD); 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD). Manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. Sold to healthcare providers worldwide. Price not disclosed.
No injuries or incidents have been reported.
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