Burlington Medical, LLC: Burlington Medical, 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, 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: R8BLOCKER1; UDI-DI (Product Code): 00840331272895 (BLOCKER8-R8BLOCKER1). 2. Model Number: R8BLOCKER2; UDI-DI (Product Code): 00840331272901 (BLOCKER8-R8BLOCKER2). 3. Model Number: R8BLOCKER3; UDI-DI (Product Code): 00840331272918 (BLOCKER8-R8BLOCKER3). 4. Model Number: R8BLOCKER4; UDI-DI (Product Code): 00840331272932 (BLOCKER8-R8BLOCKER4). 5. Model Number: R8BLOCKER5; UDI-DI (Product Code): 00840331272949 (BLOCKER8-R8BLOCKER5). 6. Model Number: R8BLOCKER6; UDI-DI (Product Code): 00840331272956 (BLOCKER8-R8BLOCKER6). 7. Model Number: S8BLOCKER1; UDI-DI (Product Code): 00840331272963 (BLOCKER8-S8BLOCKER1). 8. Model Number: S8BLOCKER2; UDI-DI (Product Code): 00840331272970 (BLOCKER8-S8BLOCKER2). 9. Model Number: S8BLOCKER3; UDI-DI (Product Code): 00840331272987 (BLOCKER8-S8BLOCKER3). 10. Model Number: U8BLOCKER1; UDI-DI (Product Code): 00840331273038 (BLOCKER8-U8BLOCKER1).
- Product quantity
- 51 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Newport News
- State
- VA
- Country
- United States
- Event id
- 98415
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