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Recall Observatory FDA recall evidence

Device product

Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780055

Z-1944-2023

May 25, 2023

Class I

Product summary

Firm
TELEFLEX LLC
Event
Event 92373
Status
Ongoing
Classification
Class I
Quantity
14480 units
Official record key
device-enforcement:Z-1944-2023

Official wording

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

Code information: UDI/DI 14026704341075, Batch Numbers: 18FG23, 18FG24, 18GG03, 18GT26, 18IT05, 18IT06, 18JG36, 18KG08, 18KG34, 18KG44, 18LG11, 18LG31, 19AG21, 19AG36, 19CT36, 19DT06, 19FT18, 19HT80, 19LT04, 20AT09, 20AT49, 20DT14, 20FT59, 20FT60, KME20H2632, KME20J1207, KME20K0629, KME20K2746, KME20L0661, KME20L1622, KME20M0351, KME21A0978, KME21A2488, KME21B1917, KME21C1735, KME21E1424, KME22C0548, KME22C0549, KME22D0160, KME22D0263, KME22E1097, KME22F1274, KME22G0791, KME22H0940, KME22H2230, KME22H2331, KME22H3266, KME22J2275, KME22J2875, KME22K2770, KME23A0296, KME23A0482, KME23A0601, KME23A2865, KME23A3176

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.