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Recall Observatory FDA recall evidence

Device product

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150020

Z-1900-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
2550 units
Official record key
device-enforcement:Z-1900-2023

Official wording

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

Code information: UDI/DI 4026704319640, Batch Numbers: 18FG01, 18FG05, 18HG07, 18HG22, 18HG27, 18HG38, 18IG02, 18JG04, 18JG06, 18JG17

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.