Device product
SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into electrical currents that can be input into a compatible pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line (Transpac units). The SafeSet reservoir is used on patients where periodic blood sampling is required.
Z-2819-2016
Product summary
- Event
- Event 74966
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125 units
- Official record key
device-enforcement:Z-2819-2016
Official wording
Reason: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Code information: 3281099 3253971 3265533
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.