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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380045

Z-1929-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
3031 units
Official record key
device-enforcement:Z-1929-2023

Official wording

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

Code information: UDI/DI 14026704340658, Batch Numbers: 18FG22, 18GT16, 18IG04, 18JG08, 19CT42, 19HT05, 19HT61, 19JT51, 19KT13, 20DT04, KME20J0756, KME20K2144, KME20L0425, KME21A2196, KME21A3268, KME21C0914, KME22D0877, KME22E0896, KME22F1601, KME22G1456, KME22G2369

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.