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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050

Z-1865-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
4146 units
Official record key
device-enforcement:Z-1865-2023

Official wording

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

Code information: UDI/DI 14026704340474, Batch Numbers: 18IG24, 18KG10, 18KG22, 18LG06, 18LG33, 19AG21, 19AG36, 19DT06, 19ET12, 19ET58, 19GT44, 19HT04, 19HT66, 19IT12, 19LT32, 20DT14, 20GG27, KME20J1208, KME21B0077, KME21C0441, KME22D3452, KME22F0736, KME22G0655

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.