ICU Medical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2128-2012)

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:

High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.

Product Classification:

Class II

Date Initiated: April 17, 2012

Date Posted: August 8, 2012

Recall Number: Z-2128-2012

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: 4625

Code Information:

Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated