Device product
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Z-1459-2014
Product summary
- Event
- Event 67774
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,700 units
- Official record key
device-enforcement:Z-1459-2014
Official wording
Reason: Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
Code information: Lot No. 13085791
Distribution pattern: USA Nationwide Distribution in the states of: AR, AZ, CA, CO, FL, ID, MD, MI, NC, NV, OK, OR, PA, TX, VA, WI
Derived failure modes
-
Unknown
Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.