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Pediatric Vari-vent mask

Canadian Hospital Specialties Limited · Model R-2800S · UDI-DI 00628725095554

BYF
10
510(k) clearances
29
Adverse events
3
Recalls
94
Facilities

Description

PEDIATRIC VARI-VENT Mask, 6 Jets - 24% to 50%, Aerosol Hood, 7FT Saflo Tube

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.