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Provox Life LaryButton 18/8
Atos Medical AB · Model 8046 · UDI-DI 07331791015151
KAC
Prescription
4
510(k) clearances
14
Adverse events (2 deaths)
1
Recalls
35
Facilities
Description
Provox Life LaryButton is a single patient use self-retaining holder for Provox Life HMEs and accessories after total laryngectomy. For patients with a shrinking tracheostomas it is also used to maintain the tracheostoma for breathing. Provox Life 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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Get your free API keyRead the docsData 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.