Device product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085
Z-1834-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 4370 units
- Official record key
device-enforcement:Z-1834-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 4026704319602, Batch Numbers: 18FG09, 18GG20, 18GG28, 18HG07, 18JG11, 18KG18, 19AG37, 19CT32, 19DT02, 19ET38, 19ET60, 19HT61, 19HT66, 19IT44, 19KT21, 19KT55, 19LT32, 20AT32, 20BT05, 20BT23, 20CT51, 20GG36, KME20L0398, KME20L2376, KME20M3247, KME21C0298, KME21E1296, KME21K1876, KME21L0573, KME22F0484
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.