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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030

Z-1861-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
3100 units
Official record key
device-enforcement:Z-1861-2023

Official wording

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

Code information: UDI/DI 14026704340436, Batch Numbers: 18GG26, 18GT26, 18JG14, 19AG21, 19CG07, 19CT69, 19DT42, 19ET34, 19FT29, 19HT04, 19IT43, 19KT17, 19LT08, 20DT15, 20DT24, 20ET56, KME20K1810, KME20M0946, KME20M2783, KME21A2389, KME21B0075, KME21B1923, KME22D1514, KME22F2666, KME22G0172, KME22G1751

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.