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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030

Z-1926-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
5990 units
Official record key
device-enforcement:Z-1926-2023

Official wording

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

Code information: UDI/DI 14026704340627, Batch Numbers: 19ET31, 19FT28, 19GT08, 19GT31, 19GT35, 19GT48, 19HT05, 19HT32, 19HT60, 19IT38, 20DT09, 20DT24, 20ET03, 20FT55, 20GT37

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.