PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: August 8, 2012 Initiated: April 17, 2012 #Z-2130-2012

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.

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
N/A
Distribution
Nationwide distribution
Location
San Clemente, CA

Frequently Asked Questions

What product was recalled?
94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing. Recalled by ICU Medical, Inc.. Units affected: N/A.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 8, 2012. Severity: Moderate. Recall number: Z-2130-2012.