FDA recall Z-1766-2019

Teleflex Medical · Class I · device

Product

Sheridan/HVT: 1) Novaplus 7.0 mm, Product Code V5-10314 2) Novaplus 7.5 mm, Product Code V5-10315 3) Novaplus 8.0 mm, Product Code V5-10316 4) Novaplus 8.5 mm, Product Code V5-10317 Product Usage: Tracheal tube/airway management

Reason for recall

This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.

Distribution

Worldwide - US Nationwide Distribution

Key facts

Status: Terminated
Initiation date: 2019-05-24
Report date: 2019-06-26
Termination date: 2022-02-15
Voluntary/Mandated: Voluntary: Firm initiated
Location: Morrisville, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1766-2019