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BR Surgical, LLC

BR Surgical, LLC · Model BR46-90001 · UDI-DI 00840183527730

510(k) clearances

Adverse events

Recalls

Facilities

Description

Myringotomy Mini Set includes, Micro Ear Fcp, Hartmann Ear Specula 2mm-4mm, Buck Ear Curette blunt, Buck Ear Curette sharp, Barbara Needle curved, Day Ear Hook, Farrell Cotton Applicator, Filter, Paper Sterilization Indicators, and Sterilization tray w/mat 12"x5 1/2"x3"

Recalls

Date	Firm	Reason
2022-11-17	MEDLINE INDUSTRIES, LP - Northfield	Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

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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.