Recall Z-2162-2014— ICU Medical, Inc.

Name: FDA recall Z-2162-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-18

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2014-07-18, terminated 2014-09-25. It names one FDA 510(k) clearance: K061573. Product: Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.. Reason: ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-07-18
Terminated: 2014-09-25
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

Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.

Reason for recall

ICU has become aware of an issue with a component where the connection on an arterial monitoring kit may crack and cause a fluid leak.

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