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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055

Z-1866-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
3309 units
Official record key
device-enforcement:Z-1866-2023

Official wording

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

Code information: UDI/DI 14026704340481, Batch Numbers: 18IG24, 18JG36, 18LG33, 19AG11, 19AG21, 19DT06, 19ET58, 19FT22, 19FT49, 19HT04, 19HT34, 19HT80, 19IT43, 19JT02, 20AT49, 20BT53, 20CT24, 20DT24, 20GG27, KME20K2673, KME20M0950, KME21A0310, KME21B0602, KME22F0738

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.