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Provox Life LaryTube 9/27 Standard

Atos Medical AB · Model 7412 · UDI-DI 07331791013676

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. Standard model can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users. The holes are punched by using Provox Fenestration Punch according to the Instructions for Use accompanying Provox Fenestration Punch. Standard model – made for use with or without a voice prosthesis. Can be attached with a Provox TubeHolder or Provox LaryClips.

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.