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Provox LaryButton 14/18

Atos Medical AB · Model 7686 · UDI-DI 07331791002748

KAC Prescription

510(k) clearances

Adverse events (2 deaths)

Recalls

Facilities

Description

Provox LaryButton is a self-retaining holder for devices in the Provox HME system intended for vocal and pulmonary rehabilitation after total laryngectomy. For patients with a shrinking tracheostomas it is also used to maintain the tracheostoma for breathing. Provox LaryButton is intended for single patient use.

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.