FDAAugust 10, 2016device

TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set, Item No. 46104-65 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 pressur...

Official recall recorded by the U.S. Food & Drug Administration.

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

FDA enforcement status: Terminated

Brands named

icu medicalicu

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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