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Recall Observatory FDA recall evidence

Device product

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140

Z-1841-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
10650 units
Official record key
device-enforcement:Z-1841-2023

Official wording

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

Code information: UDI/DI 14026704647047, Batch Numbers: 18JG17, 18JG32, 18JG34, 18KG29, 18LG02, 18LG15, 18LG18, 19AG09, 19AG21, 19BG12, 19CT32, 19DT06, 19DT20, 19ET38, 19ET72, 19ET77, 19FT24, 19JT29, 20BG16, 20CT36, 20DT37, 20ET28, 20GG45, 20GT14, KME20H2017, KME20K0772, KME20K2549, KME20K2584, KME20L1491, KME20L2402, KME21A1159, KME21A1900, KME21A2810, KME21B0572, KME21B1688, KME21C0024, KME21C0493, KME21C2999, KME21L1921, KME21L1922, KME22B1077, KME22C2262, KME22C3452, KME22E1239, KME22F0049, KME22F1951, KME22H0913, KME22H0967, KME22H2910

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.