FDA-Device2022-10-26Class I

Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)

Hazard

Incidents of device splitting or detaching during use

Sold states
US nationwide distribution
Affected count
12 units
Manufactured in
3015 Carrington Mill Blvd, N/A, Morrisville, NC, United States
Products
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0077-2023

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