ICU Medical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2129-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 17, 2012

Date Posted: August 8, 2012

Recall Number: Z-2129-2012

Event ID: 62538

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Part Number 460730418 510(k) K052865 Lot number 2444750

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated