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Medline

MEDLINE INDUSTRIES, INC. · Model HCS4685B · UDI-DI 10888277717848

BYFBYG Prescription
10
510(k) clearances
30
Adverse events
3
Recalls
95
Facilities

Description

MASK,OXYGEN,3-IN-1,PED,7,SC

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.