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Recall Observatory FDA recall evidence

Device product

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145

Z-1842-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
4320 units
Official record key
device-enforcement:Z-1842-2023

Official wording

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

Code information: UDI/DI 14026704644923, Batch Numbers: 18JG14, 18LG15, 19AG24, 19BG12, 19BG16, 19CT49, 19IT25, 20BT05, 20CT12, 20CT51, 20DT29, 20GG41, KME20H2929, KME20K1886, KME20K2586, KME20L1488, KME20L2377, KME21A1891, KME21C0019, KME21C1566, KME21C1974, KME21D0445, KME21J1149, KME21M1818, KME21M2952, KME22D1896, KME22E1744

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.