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Recall Observatory FDA recall evidence

Device product

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085

Z-1834-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
4370 units
Official record key
device-enforcement:Z-1834-2023

Official wording

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

Code information: UDI/DI 4026704319602, Batch Numbers: 18FG09, 18GG20, 18GG28, 18HG07, 18JG11, 18KG18, 19AG37, 19CT32, 19DT02, 19ET38, 19ET60, 19HT61, 19HT66, 19IT44, 19KT21, 19KT55, 19LT32, 20AT32, 20BT05, 20BT23, 20CT51, 20GG36, KME20L0398, KME20L2376, KME20M3247, KME21C0298, KME21E1296, KME21K1876, KME21L0573, KME22F0484

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.