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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040

Z-1863-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
5120 units
Official record key
device-enforcement:Z-1863-2023

Official wording

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

Code information: UDI/DI 14026704340450, Batch Numbers: 18GT26, 18KG10, 18LG33, 19AG21, 19BG12, 19CT36, 19DT42, 19FT29, 19FT49, 20DT24, KME20L2493, KME20M0278, KME21A0061, KME21B1925, KME21M1736, KME22C0700, KME22F0734, KME22G0184, KME22H0033, KME22H3078, KME22J0843

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.

Field note

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