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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380025

Z-1925-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
3590 units
Official record key
device-enforcement:Z-1925-2023

Official wording

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

Code information: UDI/DI 14026704340610, Batch Numbers: 19ET51, 19FT29, 19GT05, 19GT35, 19HT79, 19JT51, 19KT06, 19LT28, 20AT05, 20AT37, 20AT54, 20BG15, 20DT24, 20ET03, KME21B0529, KME21C0887, KME21D0327, KME21F0137, KME21K0799, KME21K0800, KME22A2704, KME22C0981, KME22C1568, KME22D0029, KME22H0686, KME22H1360

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.