FDA recall Z-0077-2023

Product

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

Reason for recall

Incidents of device splitting or detaching during use

Distribution

US nationwide distribution

Key facts

Status

Ongoing

Initiation date

2022-08-29

Report date

2022-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morrisville, NC, United States

Primary source

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