Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150

FDA Recall #Z-1843-2023 — Class I — May 25, 2023

Recall #Z-1843-2023 Date: May 25, 2023 Classification: Class I Status: Ongoing

Product Description

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150

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

2940 units

Distribution

US Nationwide distribution including Puerto Rico.

Code Information

UDI/DI 14026704644930, Batch Numbers: 18JG21, 18KG18, 19AG09, 19AG37, 19CT32, 19DT33, 19ET38, 19ET77, 19GT45, 19IT54, 20DT29, 20ET56, KME20K0157, KME20L1845, KME20L1846, KME21A0892, KME21B1697, KME21J0153, KME22B1390, KME22B2161, KME22C3335, KME22C3453, KME22F1351, KME22F2419

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated