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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380060

Z-1932-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
1110 units
Official record key
device-enforcement:Z-1932-2023

Official wording

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

Code information: UDI/DI 14026704340689, Batch Numbers: 18FG31, 19BT11, 19ET72, 19JT30, 20AT13, 20BT13, 20DT13, KME21D0600, KME21J0790, KME22A0448, KME22D1803

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.