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Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050

FDA Recall #Z-1884-2023 — Class I — May 25, 2023

Recall #Z-1884-2023 Date: May 25, 2023 Classification: Class I Status: Ongoing

Product Description

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082050

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

47520 units

Distribution

US Nationwide distribution including Puerto Rico.

Code Information

UDI/DI 14026704341389, Batch Numbers: 18GG02, 18GG19, 18GG23, 18GT06, 18JG04, 18JG15, 18JG16, 18JG18, 18JT06, 18JT16, 19AG33, 19AT20, 19BG02, 19BG03, 19BG10, 19BG15, 19BG22, 19BG26, 19BG42, 19BT04, 19CT25, 19CT82, 19DT05, 19FT38, 19IT26, 19JT18, 19LT13, 19LT17, 19LT50, 20AT13, 20AT40, 20BT38, 20CT02, 20CT12, 20CT43, 20DT13, 20ET12, 20ET17, 20ET56, 20FT23, 20GG47, 20GT32, KME20J1385, KME21G1704, KME21G1949, KME21K0151, KME21K0292, KME21M2075, KME21M2306, KME21M2649, KME22A1589, KME22A2197, KME22B1848, KME22B2478, KME22B2538, KME22B2578, KME22B2692, KME22C0066, KME22C0571, KME22D0281, KME22D2503, KME22D2504, KME22E0316, KME22E1277, KME22E1422, KME22E2743, KME22E2879, KME22G0063, KME22J0616, KME22J1331, KME22J1463, KME22K0660, KME22L1657, KME23A2133, KME23A2214, KME23A2221, KME23A2299, KME23A2358, KME23C0172

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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