Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040
FDA Recall #Z-1928-2023 — Class I — May 25, 2023
Product Description
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040
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
3370 units
Distribution
US Nationwide distribution including Puerto Rico.
Code Information
UDI/DI 14026704340641, Batch Numbers: 19FT28, 19GT04, 19GT51, 19KT13, 19LT28, 20BG15, 20ET03, KME20H2609, KME20J3088, KME20K2749, KME20L0640, KME20M1726, KME20M2538, KME21A0858, KME21M2918, KME22B2857, KME22C3373, KME22D0876
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated