Device product
Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090
Z-1835-2023
Product summary
- Firm
- TELEFLEX LLC
- Event
- Event 92373
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1460 units
- Official record key
device-enforcement:Z-1835-2023
Official wording
Reason: Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Code information: UDI/DI 4026704319619, Batch Numbers: 18FG09, 18HG27, 18IG12, 18LG18, 19GT52, 19GT65, 19HT35, 20AT25, KME20L0625, KME21E1232, KME22E2491, KME22E2912
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.