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Recall Observatory FDA recall evidence

Device product

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150

Z-1843-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
2940 units
Official record key
device-enforcement:Z-1843-2023

Official wording

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

Code information: UDI/DI 14026704644930, Batch Numbers: 18JG21, 18KG18, 19AG09, 19AG37, 19CT32, 19DT33, 19ET38, 19ET77, 19GT45, 19IT54, 20DT29, 20ET56, KME20K0157, KME20L1845, KME20L1846, KME21A0892, KME21B1697, KME21J0153, KME22B1390, KME22B2161, KME22C3335, KME22C3453, KME22F1351, KME22F2419

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.