Recall Z-0571-2017— ICU Medical, Inc.

Class II FDA medical device recall by ICU Medical, Inc., initiated 2016-09-27, terminated 2017-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS 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: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers..

Recalling firm

ICU Medical, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-09-27

Terminated

2017-07-11

Firm location

San Clemente, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.