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Omron A.I.R.S.Disposable Nebulizer Kit
Omron Healthcare, Inc. · Model 9912 · UDI-DI 00073796099121
CCQ
Prescription
1
510(k) clearances
627
Adverse events (2 deaths)
9
Recalls
147
Facilities
Description
.Disposable Nebulizer Kit with Filter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2016-10-27 | Teleflex Medical | Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication. |
| 2013-04-30 | Nephron Pharmaceuticals Corp. | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| 2013-04-30 | Nephron Pharmaceuticals Corp. | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| 2013-04-30 | Nephron Pharmaceuticals Corp. | Possible dislodgement of the "Plate A", if this instance occurs, it presents a potential choking hazard. |
| 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. |
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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.