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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060

Z-1923-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
8610 units
Official record key
device-enforcement:Z-1923-2023

Official wording

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

Code information: UDI/DI 14026704340580, Batch Numbers: 18HG21, 18KG41, 18KG43, 18LG15, 19AG01, 19BG33, 19CT33, 19ET39, 19ET40, 19ET61, 19ET65, 20CT32, KME21M2381, KME22A2300, KME22C2820, KME22D1551, KME22D2353, KME22E1009, KME22E1144, KME22E1407, KME22F2205, KME22F3384

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.