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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780065

Z-1946-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
14780 units
Official record key
device-enforcement:Z-1946-2023

Official wording

Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

Code information: UDI/DI 14026704341099, Batch Numbers: 18FG12, 18FG23, 18FG24, 18GT26, 18HG24, 18IG11, 18IG14, 18IG24, 18JG07, 18JG36, 18KG10, 18LG11, 18LG31, 19AG11, 19AG36, 19CT36, 19DT10, 19ET12, 19FT18, 19FT49, 19HT03, 19HT66, 19IT43, 19JT20, 19KT21, 19LT08, 19LT31, 20AT49, 20BT53, 20DT14, 20DT24, 20FT59, KME20H0325, KME20J1141, KME20L0727, KME20M0906, KME20M2652, KME21B0072, KME21C0332, KME21C0923, KME21C3299, KME21D0466, KME21D1903, KME21L1006, KME21L1007, KME21M1776, KME21M3025, KME21M3026, KME22A0377, KME22B1011, KME22C1836, KME22C2817, KME22D1076, KME22D2087, KME22F1763, KME22G1315, KME22G3080, KME22H0004, KME22H2233, KME22J1231, KME22J2727, KME22K0999, KME22K1158, KME22K1240, KME22M3068

Distribution pattern: US Nationwide distribution including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.