Device product
TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET" BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42620-08 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-0442-2017
Product summary
- Event
- Event 75491
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3020 units
- Official record key
device-enforcement:Z-0442-2017
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: 3242384 3264114
Distribution pattern: 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.