ICU Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0571-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 27, 2016

Date Posted: November 23, 2016

Recall Number: Z-0571-2017

Event ID: 75491

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.

Status: Terminated

Product Quantity: 40 units

Code Information:

3275023

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated