Home › SALTER LABS › Salter AIRE Elite
Salter AIRE Elite
SALTER LABS · Model 8501-0-5 · UDI-DI 10607411001229
CCQ
Prescription
10
510(k) clearances
623
Adverse events (2 deaths)
9
Recalls
145
Facilities
Description
Salter AIRE Elite™ Compressor replacement filters
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.