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FDA-Device2026-04-08Class II

Burlington Medical, Kilt

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
15,216 units
Manufactured in
3 Elmhurst St, Suite 112, Newport News, VA, United States
Products
Burlington Medical, Kilt

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1755-2026

Original summary

Burlington Medical, Kilt 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: C8K303; UDI-DI (Product Code): 00840331297638 (FKILTC18-C8K303-2XM, FKILTC8-C8K303-LF, FKILTC8-C8K303-LM, FKILTC8-C8K303-MF, FKILTC8-C8K303-MM, FKILTC8-C8K303-PLUS, FKILTC8-C8K303-SF, FKILTC8-C8K303-SM, FKILTC8-C8K303-XLF, FKILTC8-C8K303-XLM, FKILTC8-C8K303-XSF, FKILTT18-C8K303-LM, FKILTT18-C8K303-MM, FKILTT18-C8K303-PLUS, FKILTT18-C8K303-SM, FKILTT18-C8K303-XLM, FKILTT18-C8K303-XSM, FKILTT28-C8K303-2XM, FKILTT28-C8K303-4XM, FKILTT28-C8K303-5XM). 2. Model Number: R8K303; UDI-DI (Product Code): 00197513003618 (FKILTC18-R8K303-2XF ), 00197513003618 (FKILTC18-R8K303-3XF ), 00197513002932 (FKILTC8-R8K303-LF ), 00197513002925 (FKILTC8-R8K303-LM ), 00197513002918 (FKILTC8-R8K303-MF ), 00197513002901 (FKILTC8-R8K303-MM ), 00197513002888 (FKILTC8-R8K303-SF ), 00197513002871 (FKILTC8-R8K303-SM ), 00197513002864 (FKILTC8-R8K303-XLF ), 00197513000068 (FKILTT18-R8K303-LF ), 00197513000198 (FKILTT18-R8K303-LM ), 00197513000068 (FKILTT18-R8K303-MF ), 00197513000198 (FKILTT18-R8K303-MM ), 00197513000068 (FKILTT18-R8K303-PLUS ), 00197513000068 (FKILTT18-R8K303-SF ), 00197513000198 (FKILTT18-R8K303-SM ), 00197513000068 (FKILTT18-R8K303-XLF ), 00197513000198 (FKILTT18-R8K303-XLM ), 00197513000198 (FKILTT18-R8K303-XSM ), 00197513000068 (FKILTT28-R8K303-2XF ), 00197513000068 (FKILTT28-R8K303-3XF ), 00197513000198 (FKILTT28-R8K303-3XM ), 00197513000068 (FKILTT28-R8K303-4XF ), 00197513000068 (FKILTT38-R8K303-6XF ). 3. Model Number: R8KILT; UDI-DI (Product Code): None (IKILTC8-R8KILT-LMR ), None (IKILTC8-R8KILT-SMR ), 00840331259681 (KILTC18-R8KILT-2XF ), 00840331259698 (KILTC18-R8KILT-2XM ), 00840331259704 (KILTC18-R8KILT-3XF ), 00840331259711 (KILTC18-R8KILT-3XM ), 00840331259728 (KILTC8-R8KILT-LF ), 00840331259735 (KILTC8-R8KILT-LM ), 00840331259735 (KILTC8-R8KILT-MF ), 00840331259759 (KILTC8-R8KILT-MM ), 00840331259766 (KILTC8-R8KILT-PLUS ), 00840331259773 (KILTC8-R8KILT-SF ), 00840331259780 (KILTC8-R8KILT-SM ), 00840331259797 (KILTC8-R8KILT-XLF ), 00840331259803 (KILTC8-R8KILT-XLM ), 00840331259810 (KILTC8-R8KILT-XSF ), 00840331259827 (KILTC8-R8KILT-XSM ), 00840331259728 (KILTS8-R8KILT-LF ), 00840331259735 (KILTS8-R8KILT-LM ), 00840331259742 (KILTS8-R8KILT-MF ), 00840331259759 (KILTS8-R8KILT-MM ), 00840331259766 (KILTS8-R8KILT-PLUS ), 00840331259773 (KILTS8-R8KILT-SF ), 00840331259780 (KILTS8-R8KILT-SM ), 00840331259797 (KILTS8-R8KILT-XLF ), 00840331259803 (KILTS8-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-LF ), 00840331269932 (KILTT18-R8KILT-LM ), 00840331269925 (KILTT18-R8KILT-MF ), 00840331269932 (KILTT18-R8KILT-MM ), 00840331269925 (KILTT18-R8KILT-PLUS ), 00840331269925 (KILTT18-R8KILT-SF ), 00840331269932 (KILTT18-R8KILT-SM ), 00840331269925 (KILTT18-R8KILT-XLF ), 00840331269932 (KILTT18-R8KILT-XLM ), 00840331269925 (KILTT18-R8KILT-XSF ), 00840331269932 (KILTT18-R8KILT-XSM ), 00840331269925 (KILTT28-R8KILT-2XF ), 00840331269932 (KILTT28-R8KILT-2XM ), 00840331269925 (KILTT28-R8KILT-3XF ), 00840331269932 (KILTT28-R8KILT-3XM ), 00840331269925 (KILTT28-R8KILT-4XF ), 00840331269932 (KILTT28-R8KILT-4XM ), 00840331269925 (KILTT28-R8KILT-5XF ), 00840331269932 (KILTT28-R8KILT-5XM ), 00840331269925 (KILTT38-R8KILT-6XF ), 00840331269932 (KILTT38-R8KILT-6XM ), 00840331269925 (KILTT38-R8KILT-7XF ), 00840331269932 (KILTT38-R8KILT-7XM ), 00840331269925 (KILTT38-R8KILT-8XF ), 00840331269932 (KILTT38-R8KILT-8XM ), None (IKILTC8-R8KILT-LFL ), None (IKILTC8-R8KILT-LFR ), None (IKILTC8-R8KILT-MFL ), None (IKILTC8-R8KILT-MFR ), None (IKILTC8-R8KILT-MFXL ), None (IKILTC8-R8KILT-MML ), None (IKILTC8-R8KILT-MMR ), None (IKILTC8-R8KILT-SFL ), None (IKILTC8-R8KILT-SML ), None (IKILTC8-R8KILT-XSFR ), None (IKILTC8-R8KILT-2XFL ), None (IKILTC8-R8KILT-2XFR ), None (IKILTC8-R8KILT-3XFR ), None (IKILTC8-R8KILT-LFS ), None (IKILTC8-R8KILT-LML ), None (IKILTC8-R8KILT-LMXL ), None (IKILTC8-R8KILT-MFS ), None (IKILTC8-R8KILT-SFS ), None (IKILTC8-R8KILT-XLMR ), None (IKILTC8-R8KILT-2XMXL ), None (IKILTC8-R8KILT-PLUSL ), None (IKILTC8-R8KILT-SFR ), None (IKILTC8-R8KILT-XLML ), None (IKILTC8-R8KILT-XSFS ), None (IKILTC8-R8KILT-MMXL ), None (IKILTC8-R8KILT-XLMXL ), None (IKILTC8-R8KILT-2XMR ), None (IKILTC8-R8KILT-XSML ), None (IKILTC8-R8KILT-XSMR ), None (IKILTC8-R8KILT-XSMXL ), None (IFKILTC8-R8K303-LFR), None (IFKILTC8-R8K303-MMR). 4. Model Number: R8S302; UDI-DI (Product Code): 00197513004950 (SKIRTWBC8-R8S302-LF ), 00197513004943 (SKIRTWBC8-R8S302-LM ), 00197513004936 (SKIRTWBC8-R8S302-MF ), 00197513004929 (SKIRTWBC8-R8S302-MM ), 00197513004912 (SKIRTWBC8-R8S302-PLUS ), 00197513004905 (SKIRTWBC8-R8S302-SF ), 00197513004899 (SKIRTWBC8-R8S302-SM ), 00197513004875 (SKIRTWBC8-R8S302-XLM ), 00197513000327 (SKIRTWBT18-R8S302-LF ), 00197513000457 (SKIRTWBT18-R8S302-LM ), 00197513000327 (SKIRTWBT18-R8S302-MF ), 0

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