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Adult CO2 /O2 Mask

WESTMED, INC. · Model 0931 · UDI-DI 00709078006876

BSJCCK Prescription
10
510(k) clearances
115
Adverse events
1
Recalls
161
Facilities

Description

Pediatric Elongated CO2/O2 Mask 7' Tubing w/ Threaded Nut, Swivel GSE, 10' x 0.38" ID x .107" OD, Reflective Luer Connectors

Recalls

DateFirmReason
2011-09-12Engineered Medical Systems,IncThe mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.