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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095

Z-1882-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
760 units
Official record key
device-enforcement:Z-1882-2023

Official wording

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

Code information: UDI/DI 14026704341266, Batch Numbers: 18IT25, 18JG13, 19CT66, 19HT79, 19KT08, 20BT13, 20DT19, KME22C0673

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.