Recall Z-2130-2012— ICU Medical, Inc.

Name: FDA recall Z-2130-2012
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: K964435. Product: 94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing. 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

K964435 — PRIMARY IV SETIcu Medical, Inc.·cleared 1997-04-02

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

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

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.