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BR Surgical, LLC

BR Surgical, LLC · Model BR980-9105 · UDI-DI 00840183512941

OGS Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Myringotomy Kit, (5) per box, consisting of Ear Tube (Pope), Ear Tube (T Tube), Myringotomy Blade, Plastic Ear Speculum 4mm and 6mm, Gauze 4x4 12 ply (2), Large Cotton Ball (2), 2-Compartment Tray, CSR 20x20 Wrap, 10x15 Peel Pouch

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.