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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075

Z-1877-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
15810 units
Official record key
device-enforcement:Z-1877-2023

Official wording

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

Code information: UDI/DI 14026704341112, Batch Numbers: 18FG21, 18FG31, 18GG19, 18HG23, 18HG30, 18IG16, 18IG30, 18JG35, 18KG19, 18KG41, 18LG18, 19AG03, 19BG04, 19BG19, 19CG03, 19CT36, 19DT34, 19FT37, 19GT65, 19HT55, 19IT01, 19IT19, 19JT38, 19LT21, 20AT26, 20BG11, 20CT12, 20DT22, 20ET04, 20ET49, 20FT65, KME20H0627, KME20K0991, KME20K3625, KME20L2680, KME21A1113, KME21A2088, KME21A3085, KME21B0714, KME21B2708, KME21C0596, KME21C1167, KME21L0761, KME21L0859, KME22A1383, KME22B2543, KME22B2906, KME22D0652, KME22D3251, KME22E1151, KME22E1506, KME22G0386, KME22G3151, KME22G3270, KME22H2700, KME22J0257, KME22J1105, KME22J1335, KME22K3101, KME22M1594

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.