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PEGASUS

PEGASUS RESEARCH CORPORATION · Model P6200 · UDI-DI 00612223062019

BYF Prescription
10
510(k) clearances
27
Adverse events
3
Recalls
94
Facilities

Description

FLO2 STANDARD FLOW OXYGEN DILUTER, ADULT KIT

Recalls

DateFirmReason
2011-03-25Salter Laboratories, Division of Regulatory AffairsA small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
2011-02-11Smiths MedicalA sticky substance on the inside and/ or outside of the Mask
2011-02-11Smiths MedicalA sticky substance on the inside and/ or outside of the Mask

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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.