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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040

Z-1871-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
12852 units
Official record key
device-enforcement:Z-1871-2023

Official wording

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

Code information: UDI/DI 14026704340542, Batch Numbers: 18GG17, 18GG34, 18IG15, 18JG03, 18JG21, 18KG18, 18LG14, 18LG15, 19AG25, 19BG02, 19ET39, 19FT46, 19HT31, 19IT01, 19IT53, 19KT02, 19LT21, 20AT26, 20CT11, 20DT19, 20DT32, KME20J0427, KME20M0303, KME21A2096, KME21A3064, KME21B2620, KME21B2621, KME21C1148, KME21C3436, KME21D0720, KME21D2148, KME21M2369, KME22B0041, KME22B0278, KME22B0588, KME22C0507, KME22D3254, KME22F0607, KME22F2175

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.