Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100

FDA Recall #Z-1860-2023 — Class I — May 25, 2023

Recall #Z-1860-2023 Date: May 25, 2023 Classification: Class I Status: Ongoing

Product Description

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 1700100

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

190 units

Distribution

US Nationwide distribution including Puerto Rico.

Code Information

UDI/DI 4026704319633, Batch Numbers: 18IG06, 18KG44

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated