PlainRecalls
FDA Devices Moderate Class II Terminated

Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 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 th

Reported: November 23, 2016 Initiated: September 27, 2016 #Z-0491-2017

Product Description

Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 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.

Reason for Recall

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
70 units
Distribution
Nationwide Distribution
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled? ▼
Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 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.. Recalled by ICU Medical, Inc.. Units affected: 70 units.
Why was this product recalled? ▼
ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0491-2017.

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