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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180035

Z-1862-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
4769 units
Official record key
device-enforcement:Z-1862-2023

Official wording

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

Code information: UDI/DI 14026704340443, Batch Numbers: 18IG24, 18JG07, 18LG06, 18LG33, 19AG36, 19CT69, 19DT42, 19ET34, 19FT19, 19FT29, 19HT34, 19IT43, 19JT02, 19LT08, 19LT32, 20ET56, KME20K1811, KME20M0947, KME21A0060, KME21A2390, KME21B0599, KME22D1515, KME22G0175, KME22K0607, KME22K3167, KME23A1884

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.