Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020

FDA Recall #Z-1900-2023 — Class I — May 25, 2023

Recall #Z-1900-2023 Date: May 25, 2023 Classification: Class I Status: Ongoing

Product Description

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020

Reason for Recall

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Recalling Firm

TELEFLEX LLC — Morrisville, NC

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

2550 units

Distribution

US Nationwide distribution including Puerto Rico.

Code Information

UDI/DI 4026704319640, Batch Numbers: 18FG01, 18FG05, 18HG07, 18HG22, 18HG27, 18HG38, 18IG02, 18JG04, 18JG06, 18JG17

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated