Device product
CE17TKFCS CONT EPID TRAY W/17G TUOHY-LF, Material Number 332097 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.
Z-3343-2018
Product summary
- Event
- Event 80811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 93140
- Official record key
device-enforcement:Z-3343-2018
Official wording
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Code information: Batch: 61588414, 61587114, 61590499, 61591305, 61591822, 61592516, 61595497, 61596327, 61597457, 61598516, 61594208, 61600757, 61602063, 61609687, 61611125, 61612545, 61614791, 61615905, 61605299, 61616952, 61618405, 61619350, 61620436, 61622088, 61620983, 61623759, 61622734, 61586767
Distribution pattern: Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.
Derived failure modes
-
Unknown
The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.