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601

BURLINGTON MEDICAL, LLC · Model RE601-PLUS · UDI-DI 00840186698024

IWO
1
510(k) clearances
5
Adverse events
13
Recalls
80
Facilities

Description

Custom 601: Frontal Apron with Velcro Shoulder Closure (Quick Drop OR Apron) .5mm Enviro-Lite Size Female Large Plus

Recalls

DateFirmReason
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.
2026-02-11Burlington Medical, LLCPotential for attenuation degradation over time, decreasing the lifespan.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.