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Provox LaryTube 9/55 with Ring

Atos Medical AB · Model 7627 · UDI-DI 07331791002373

KAC Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

Provox LaryTube is a holder for devices in the Provox HME System intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostoma it is also used to maintain the tracheostoma for breathing. The Provox LaryTube is intended for single patient use. The model with ring is made for use with or without a voice prosthesis. The model with ring can be fenestrated so that air can go through the voice prosthesis for voice prosthesis users.

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.