FDAFDA · Food and drugs·Recall number Z-0441-2017
TRANSPAC¿ IV MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42608-05 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.
Published November 23, 2016 · Recall initiated: September 27, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Nationwide Distribution
- Lot
- 3226306 3251016 3264112
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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