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Mask ventkit O2Star adjust M/L
Drägerwerk AG & Co. KGaA · Model MP01922 · UDI-DI 04048675382249
10
510(k) clearances
27
Adverse events
3
Recalls
94
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-25 | Salter Laboratories, Division of Regulatory Affairs | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
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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.