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Neotech RAM Cannula®

Neotech Products LLC · Model Blue - New-Born · UDI-DI 10812594011297

CAT Prescription

510(k) clearances

1,798

Adverse events (30 deaths)

Recalls

264

Facilities

Description

"The Neotech RAM Cannula is intended to be used for preterm and term neonates, infants, and pediatric patients who require supplemental oxygen, respiratory support or assistance in breathing in an ambulatory, hospital or institutional environment. It is used to provide oxygen with the following methods: 1. Heated or unheated, humidified low flow oxygen. 2. Heated, humidified high flow oxygen."

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.