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Masimo
HYGIA HEALTH SERVICES, INC. · Model 1862 · UDI-DI 10817357020189
1
510(k) clearances
89
Adverse events
3
Recalls
19
Facilities
Description
Masimo Neonatal SpO2 Adhesive Sensors, 3 ft.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2008-03-11 | Ascent Healthcare Solutions, Inc. | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
| 2008-03-11 | Ascent Healthcare Solutions, Inc. | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
| 2008-03-11 | Ascent Healthcare Solutions, Inc. | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
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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.