Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
FDA Recall #Z-1828-2023 — Class I — May 25, 2023
Product Description
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
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
3530 units
Distribution
US Nationwide distribution including Puerto Rico.
Code Information
UDI/DI 4026704319541, Batch numbers: 18FG18, 18GG14, 18GG31, 18HG22, 18KG23, 19BG12, 19ET72, 19IT25, 20AT25, 20AT32, 20BT05, 20BT37, 20BT47, 20ET21, KME20G0383, KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21G0756, KME21M0313, KME21M1832, KME22B0193, KME22D1787, KME22F1665
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated