Recall Z-0432-2017— ICU Medical, Inc.

Name: FDA recall Z-0432-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-27

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2016-09-27, terminated 2017-07-11. It names one FDA 510(k) clearance: K061573. Product: TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 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.. 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

510(k) clearances named in this recall

1 on FDA's record

K061573 — TRANSPAC III DISPOSABLE STRAIGHT PRESSURE TRANSDUCER AND KITHospira, Inc.·cleared 2006-09-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24", WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP), Item No. 42588-05 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.

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.

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