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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055

Z-1922-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
24752 units
Official record key
device-enforcement:Z-1922-2023

Official wording

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

Code information: UDI/DI 14026704340573, Batch Numbers: 18FT35, 18GG18, 18GG23, 18GT32, 18IG16, 18JG35, 18KG01, 18KG39, 18LG15, 18LG18, 18LG39, 19AG01, 19AG25, 19CG02, 19CT33, 19DT05, 19DT35, 19ET36, 19ET61, 19ET65, 19KT02, 20AT26, 20CT11, 20DT19, KME21A2087, KME21B1774, KME21B2624, KME21B2710, KME21B2711, KME21C0549, KME22A0758, KME22A2298, KME22A2299, KME22B1465, KME22B1666, KME22B2680, KME22C2315, KME22C2316, KME22D1671, KME22D2352, KME22E1006, KME22E1007, KME22E1406, KME22E1930, KME22F2204, KME22F2482

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.