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Recall Observatory FDA recall evidence

Device product

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170155

Z-1844-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
3310 units
Official record key
device-enforcement:Z-1844-2023

Official wording

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

Code information: UDI/DI 14026704644947, Batch Numbers: 18JG17, 19AG37, 19CT32, 19ET22, 19ET38, 19ET60, 19IT54, 20AT32, 20CT22, 20DT29, KME20G0385, KME20K2550, KME20L1492, KME20M0813, KME21A2775, KME21B1698, KME21C2646, KME21J0882, KME21J0883, KME22F0239, KME22F0718, KME22F2420, KME22J0254, KME22J0262, KME22K2780

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.