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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380055

Z-1931-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
1670 units
Official record key
device-enforcement:Z-1931-2023

Official wording

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

Code information: UDI/DI 14026704340672, Batch Numbers: 19ET11, 19GT51, 19JT20, 20AT13, KME20H2315, KME21A2778, KME22A0155, KME22A2335, KME22E0288, KME22E1272, KME22F1551

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.