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ETCO2 Nasal Cannula

DISTRIBUTION UNLIMITED, LLC · Model 1 · UDI-DI 00850014433215

CAT

510(k) clearances

1,812

Adverse events (30 deaths)

Recalls

266

Facilities

Description

A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to simultaneously deliver oxygen (O2) and allow sampling of exhaled gas for carbon dioxide (CO2) monitoring through separate prongs.

Recalls

Date	Firm	Reason
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2018-07-06	Smiths Medical ASD Inc.	"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
2017-05-09	Teleflex Medical	Incorrect 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.