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Recall Observatory FDA recall evidence

Device product

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082100

Z-1894-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
19250 units
Official record key
device-enforcement:Z-1894-2023

Official wording

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

Code information: UDI/DI 14026704341488, Batch Numbers: 18GG13, 18JG24, 18JG36, 18JT06, 18KG10, 18LG06, 19AG36, 19CG02, 19GT16, 19GT59, 19IT33, 19JT56, 19KT14, 19KT49, 20AT01, 20AT22, 20BG18, 20DT18, 20DT19, 20ET17, KME20H2141, KME20K1809, KME20K2553, KME20L0335, KME20M1341, KME20M2113, KME21A2342, KME21A2668, KME21C0017, KME21F2252, KME21F2345, KME22B1777, KME22B1881, KME22C0019, KME22C0063, KME22C0327, KME22E2679, KME22F0401, KME22H0209, KME22H2251, KME22J2931, KME22J3329, KME22L0218, KME22L0219, KME22L2730, KME22L2731, KME23A2196, KME23A2539, KME23A3169

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.