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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180045

Z-1864-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
4155 units
Official record key
device-enforcement:Z-1864-2023

Official wording

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

Code information: UDI/DI 14026704340467, Batch Numbers: 18GT26, 18KG10, 18LG06, 19AG11, 19AG21, 19CT69, 19DT06, 19FT29, 19FT49, 19GT43, 19HT66, 19JT55, 19KT17, 19LT08, 19LT32, 20AT49, 20BT53, 20DT15, 20ET04, 20GG27, KME20H2636, KME20K1812, KME20K2573, KME21L2619, KME21M1773, KME22E2900, KME22G0347, KME22J3224, KME22K0489

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.