Device product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
Z-1957-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 8620 units
- Official record key
device-enforcement:Z-1957-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 14026704341242, Batch Numbers: 18GG18, 18HG21, 18IG16, 18KG01, 18KG19, 18LG18, 19BG18, 19BG33, 19GT13, 19HT31, 19HT55, 19IT15, 19JT35, 19KT14, 19LT21, 20AT26, 20CT11, 20FT68, 20GT49, KME20M0409, KME21A1111, KME21A2095, KME21B2212, KME21C2483, KME21C3405, KME22B0921, KME22B0923, KME22D0289, KME22D1811, KME22D1855, KME22D2401, KME22E2898, KME22H2600, KME22H3295, KME22J2877, KME22K2861, KME22K3117, KME22M1510, KME22M2546, KME23B0521, KME23B3047
Distribution pattern: US Nationwide distribution including Puerto Rico.
Derived failure modes
-
Unknown
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.