Recall Z-2129-2012— ICU Medical, Inc.

Name: FDA recall Z-2129-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-17

Class II · Terminated

Class II FDA medical device recall by ICU Medical, Inc., initiated 2012-04-17, terminated 2012-08-23. It names one FDA 510(k) clearance: K052865. Product: Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.. Reason: The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-04-17
Terminated: 2012-08-23
Firm location: San Clemente, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K052865 — HOSPIRA CATH LAB CONVENIENCE KITSIcu Medical, Inc.·cleared 2005-12-22

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

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.

Reason for recall

The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.

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