FDA-Device2026-04-08Class II

Burlington Medical, Caps.

Burlington Medical, LLC

Hazard

Potential for attenuation degradation over time, decreasing the lifespan.

Sold states

Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam.

Affected count

961 units

Manufactured in

3 Elmhurst St, Suite 112, Newport News, VA, United States

Products

Burlington Medical, Caps.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1760-2026

Original summary

Burlington Medical, Caps. Potential for attenuation degradation over time, decreasing the lifespan. All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8CAP; UDI-DI (Product Code): 00840331272185 (CAP8-R8CAP-LG_XL), 00840331272178 (CAP8-R8CAP-SM_MD). 2. Model Number: S8CAP; UDI-DI (Product Code): 00840331272208 (CAP8-S8CAP-LG_XL), 00840331272192 (CAP8-S8CAP-SM_MD). 3.Model Number: U8CAP; UDI-DI (Product Code): 00840331272222 (CAP8-U8CAP-LG_XL), 00840331272215 (CAP8-U8CAP-SM_MD). Distribution: Worldwide distribution. Nationwide distribution in the US and international distribution to Canada, Australia, Bangladesh, Chile, Hong Kong, India, Mexico, Malaysia, Panama, Singapore, Thailand, Taiwan, Uruguay, and Vietnam. Affected quantity: 961 units

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