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MasimoSET Reprocessed LNCS® Adtx SpO2 Adult Pulse Oximeter Adhesive Sensor

MASIMO CORPORATION · Model 2686 · UDI-DI 10843997003350

NLF Prescription
10
510(k) clearances
93
Adverse events
3
Recalls
19
Facilities

Recalls

DateFirmReason
2008-03-11Ascent Healthcare Solutions, Inc.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
2008-03-11Ascent Healthcare Solutions, Inc.Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
2008-03-11Ascent 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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Data 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.