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Provox Life LaryTube 12/55 Fenestrated with Ring

Atos Medical AB · Model 8055 · UDI-DI 07331791015014

KAC Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

Provox Life LaryTube is a single patient use device intended to provide attachment for Provox Life HME and accessories after total laryngectomy. For laryngectomized patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. Fenestrated with ring model – made for voice prosthesis users. Can only be attached with a Provox Life Adhesive.

Recalls

Date	Firm	Reason
2006-12-15	Smiths Medical ASD, Inc.	The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.

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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.