Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
FDA Recall #Z-1929-2023 — Class I — May 25, 2023
Product Description
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045
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
3031 units
Distribution
US Nationwide distribution including Puerto Rico.
Code Information
UDI/DI 14026704340658, Batch Numbers: 18FG22, 18GT16, 18IG04, 18JG08, 19CT42, 19HT05, 19HT61, 19JT51, 19KT13, 20DT04, KME20J0756, KME20K2144, KME20L0425, KME21A2196, KME21A3268, KME21C0914, KME22D0877, KME22E0896, KME22F1601, KME22G1456, KME22G2369
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated