ICU Medical, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2130-2012)

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:

94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing

Product Classification:

Class II

Date Initiated: April 17, 2012

Date Posted: August 8, 2012

Recall Number: Z-2130-2012

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 B30059 510(k) K964435 Lot number 2418897, 2423996, 2425137, 2430044, 2431861, 2436569, 2443559, 2447238, 2448099, 2452377, 2457453, 2459025, 2464569, 2467687.

Distribution Pattern:

Nationwide distribution

Voluntary or Mandated:

Voluntary: Firm initiated