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Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070

FDA Recall #Z-1956-2023 — Class I — May 25, 2023

Recall #Z-1956-2023 Date: May 25, 2023 Classification: Class I Status: Ongoing

Product Description

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070

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

35513 units

Distribution

US Nationwide distribution including Puerto Rico.

Code Information

UDI/DI 14026704341228, Batch Numbers: 18GG17, 18GG25, 18GT32, 18HG19, 18IG16, 18JG13, 18JG21, 18KG01, 18LG12, 18LG15, 18LG30, 19AG15, 19AG25, 19AG29, 19BG03, 19CT56, 19GT17, 19HT02, 19HT31, 19HT68, 19HT69, 19IT19, 19JT11, 19JT35, 19KT02, 19LT21, 20AT22, 20BG11, 20CT11, 20DT22, 20DT35, 20FT64, 20FT68, 20GT34, 20GT49, KME20H0436, KME20H2683, KME20M0445, KME20M2650, KME21A2042, KME21A2083, KME21A2187, KME21A2929, KME21B0718, KME21B1715, KME21B1946, KME21C0552, KME21C1043, KME21C1044, KME21C1910, KME21C1912, KME21F1682, KME21F1864, KME21K1635, KME21M0798, KME21M2432, KME22A0810, KME22A2177, KME22A2883, KME22A2924, KME22A3263, KME22B2796, KME22C0042, KME22C0206, KME22C0505, KME22D2264, KME22D3154, KME22E1996, KME22E2224, KME22E2513, KME22F0202, KME22H0792, KME22H1588, KME22H2923, KME22J1124, KME22J2482, KME22J3020

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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