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Recall Observatory FDA recall evidence

Device product

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170050

Z-1827-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
11560 units
Official record key
device-enforcement:Z-1827-2023

Official wording

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

Code information: UDI/DI: 4026704319534, Batch numbers: 18FG05, 18GG08, 18GT32, 18HG38, 18JG02, 18JG11, 18KG15, 18LG22, 19AG24, 19DT06, 19DT33, 19ET28, 19FT18, 19IT25, 19KT48, 20AT14, 20DT09, 20ET04, 20GT31, KME20J1235, KME20J1238, KME20K2551, KME20L1089, KME20L2371, KME21A2064, KME21B2498, KME21F1552, KME21G1708, KME21K1248, KME21M2648, KME22B1391, KME22D1768, KME22D1769

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.