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Provox® FreeHands HME® Casette
Atos Medical AB · Model 7711 · UDI-DI 07331791005022
EWL
Prescription
10
510(k) clearances
176
Adverse events (3 deaths)
4
Recalls
5
Facilities
Description
The Freehands HME Cassette heats and humidifies the inhaled air and partially restores breathing resistance. The FreeHands HME Cassette should only be used with the Provox Freehands automatic speech valve.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-17 | Freudenberg Medical, LLC | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang |
| 2026-06-17 | Freudenberg Medical, LLC | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large Esophageal and Tracheal Flang |
| 2013-10-01 | Helix Medical LLC | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATS |
| 2012-03-08 | Helix Medical LLC | Helix Medical LLC is recalling the BLOM-SINGER indwelling TEP Occluder due to an invalid expiration date. |
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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.