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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050

Z-1930-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
4110 units
Official record key
device-enforcement:Z-1930-2023

Official wording

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

Code information: UDI/DI 14026704340665, Batch Numbers: 18FG05, 18FT26, 18GT27, 18IG06, 18JG20, 18LG03, 18LT24, 19BG30, 19CT50, 19DT17, 19KT21, 19LT51, 20AT26, 20AT41, 20CT43, 20DT13, 20GG27, KME20H2359, KME20K1713, KME20L1811, KME20M2219, KME21A2253, KME21B0984, KME21L0988, KME22D2223, KME22D3339, KME22E0284, KME22F3118, KME22H2816

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.