Burlington Medical, LLC: Burlington Medical, Kilt Blockers.
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Burlington Medical, LLC
- Product
- Burlington Medical, Kilt Blockers.
- Reason / hazard
- Potential for attenuation degradation over time, decreasing the lifespan.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2026-02-11
- Code info
- All serial numbers are affected that were manufactured with Xenolite 800 attenuation material from 01/16/2025 to 01/21/2026. 1. Model Number: R8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272727 (KILTBLOCKER8-R8KILTBLOCKER10X12). 2. Model Number: R8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011293 (KILTBLOCKER8-R8KILTBLOCKER12X12). 3. Model Number: R8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272741 (KILTBLOCKER8-R8KILTBLOCKER18X20). 4. Model Number: R8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272758 (KILTBLOCKER8-R8KILTBLOCKER20X24). 5. Model Number: R8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272765 (KILTBLOCKER8-R8KILTBLOCKER24X24). 6. Model Number: S8KILTBLOCKER10X10; UDI-DI (Product Code): 00840331272772 (KILTBLOCKER8-S8KILTBLOCKER10X10). 7. Model Number: S8KILTBLOCKER10X12; UDI-DI (Product Code): 00840331272789 (KILTBLOCKER8-S8KILTBLOCKER10X12). 8. Model Number: S8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011309 (KILTBLOCKER8-S8KILTBLOCKER12X12). 9. Model Number: S8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272802 (KILTBLOCKER8-S8KILTBLOCKER18X20). 10. Model Number: S8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272819 (KILTBLOCKER8-S8KILTBLOCKER20X24). 11. Model Number: S8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272826 (KILTBLOCKER8-S8KILTBLOCKER24X24). 12. Model Number: U8KILTBLOCKER12X12; UDI-DI (Product Code): 00197513011316 (KILTBLOCKER8-U8KILTBLOCKER12X12). 13. Model Number: U8KILTBLOCKER18X20; UDI-DI (Product Code): 00840331272864 (KILTBLOCKER8-U8KILTBLOCKER18X20). 14. Model Number: U8KILTBLOCKER20X24; UDI-DI (Product Code): 00840331272871 (KILTBLOCKER8-U8KILTBLOCKER20X24). 15. Model Number: U8KILTBLOCKER24X24; UDI-DI (Product Code): 00840331272888 (KILTBLOCKER8-U8KILTBLOCKER24X24).
- Product quantity
- 94 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Newport News
- State
- VA
- Country
- United States
- Event id
- 98415
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