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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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.
Attenuation degradation over time. This can decrease the lifespan of the attenuation in the caps and potentially affect device performance.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Burlington Medical, LLC for recall instructions. 3. Follow the provided recall guidance for replacement or disposition. 4. Use the FDA recall page for official updates and instructions.
Phone: Unknown. Website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1760-2026. Hours: Unknown.
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