ICU Medical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0415-2017)

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:

TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP, Item No. 011-42584-05 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.

Product Classification:

Class II

Date Initiated: September 27, 2016

Date Posted: November 23, 2016

Recall Number: Z-0415-2017

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: 60,560 units

Code Information:

3192360 3210327 3225634 3242228 3242233 3242235 3242236 3242237 3242245 3242247 3242248 3242249 3242255 3242260 3242262 3242263 3253912 3264057 3264059 3264062 3264063 3273065 3273070 3273071 3284136

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated