Device product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055
Z-1828-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 3530 units
- Official record key
device-enforcement:Z-1828-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 4026704319541, Batch numbers: 18FG18, 18GG14, 18GG31, 18HG22, 18KG23, 19BG12, 19ET72, 19IT25, 20AT25, 20AT32, 20BT05, 20BT37, 20BT47, 20ET21, KME20G0383, KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21G0756, KME21M0313, KME21M1832, KME22B0193, KME22D1787, KME22F1665
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.