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Comfort Soft Plus CO2/O2 Mask

WESTMED, INC. · Model 0562 · UDI-DI 00709078001697

CATCAI Prescription
10
510(k) clearances
1,767
Adverse events (30 deaths)
6
Recalls
263
Facilities

Description

adult CO2/O2 Mask, 10' x 0.050 GSL w swivel elbow, 2" Pigtail w/ female luer connectors, 7' oxygen supply tubing

Recalls

DateFirmReason
2018-07-06Smiths Medical ASD Inc."Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06Smiths Medical ASD Inc."Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06Smiths Medical ASD Inc."Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06Smiths Medical ASD Inc."Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06Smiths Medical ASD Inc."Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2017-05-09Teleflex MedicalIncorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.

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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.