Recall Z-0530-2017— ICU Medical, Inc.

Name: FDA recall Z-0530-2017
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: CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The 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.-75. 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

CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The 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.-75

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.