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Recall Observatory FDA recall evidence

Device product

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170095

Z-1836-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
720 units
Official record key
device-enforcement:Z-1836-2023

Official wording

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

Code information: UDI/DI 4026704319626, Batch Numbers: 19HT48, 19KT17, 20AT53, 20BT37, KME22E2493, KME22F1387, KME22H0342

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.