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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380040

Z-1928-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
3370 units
Official record key
device-enforcement:Z-1928-2023

Official wording

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

Code information: UDI/DI 14026704340641, Batch Numbers: 19FT28, 19GT04, 19GT51, 19KT13, 19LT28, 20BG15, 20ET03, KME20H2609, KME20J3088, KME20K2749, KME20L0640, KME20M1726, KME20M2538, KME21A0858, KME21M2918, KME22B2857, KME22C3373, KME22D0876

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.