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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075

Z-1880-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
17840 units
Official record key
device-enforcement:Z-1880-2023

Official wording

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

Code information: UDI/DI 14026704341235, Batch Numbers: 18FG21, 18GG18, 18GG19, 18HG29, 18IG17, 18JG03, 18JG20, 18JG35, 18KG01, 18KG43, 18LG18, 19AG25, 19BG03, 19BG18, 19BG20, 19DT38, 19ET36, 19FT02, 19HT55, 19HT68, 19IT53, 19LT36, 20AT26, 20BG11, 20CT11, 20DT19, 20FT64, 20GT11, 20GT34, KME20J1216, KME20K3678, KME20L0953, KME20M1291, KME21A1263, KME21A2084, KME21B1948, KME21B1950, KME21C1040, KME21C1041, KME21C2485, KME21C3404, KME21F0144, KME21F1428, KME21K1054, KME21K2543, KME21L2839, KME22A0811, KME22A1220, KME22A2928, KME22B0589, KME22B2683, KME22C2313, KME22D0105, KME22D0296, KME22D0589, KME22D3070, KME22E1853, KME22E2748, KME22F0603, KME22G0210, KME22G1168, KME22H1123, KME22H3070, KME22J1084, KME22K2080, KME22K2470, KME22L0201, KME22L0202, KME23A1196

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.