Recall Class: Class I

Date Recall Initiated: August 19, 2014

Product(s): ConMed Stat2 Flow Controller, used in intravenous (IV) administration sets

• Manufacturing Dates: October, 2013 – January, 2014
• Distribution Dates: October, 2013 - January, 2014.
• Item numbers: 011-C9801, 011-C9802, AH7007, B9897, Z2648
• Affected Lot numbers: 2768416, 2768417, 2758229, 2785379, 2801951, 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL

Use: IV administration sets contain hypodermic needles and tubing. They are used to deliver or remove fluids from the body, in humans or animals. The amount of fluid delivered is controlled by a flow controller.

Recalling Firm: 
ICU Medical, Incorporated
951 Calle Amanecer 
San Clemente, CA 92673

Reason for Recall: ICU Medical Inc., is recalling the Stat2 Flow Controller because it was assembled with the wrong internal component. As a result, the Flow Controller may deliver fluid at a much higher flow rate than what is set.

The use of the affected product may cause serious adverse health consequences, including death.

Public Contact: 
Should you have any questions about this recall contact ICU Customer Service at 866-829-9025 (Option 8), Monday through Friday, 8:30 AM - 4:00 PM Pacific Time or e-mail customerservice@icumed.com

FDA District: Los Angeles District

More Information about this Recall:  
On August 19, 2014, ICU Medical Inc. sent an Urgent Medical Device Recall Notification letter to affected customers and authorized distributors. The letter identified the affected product, problem and actions to be taken. The letter advises customers to:

• Remove the affected devices from use and return them to ICU Medical, Inc.
• Complete sections A and B of the Recall Response Form included with the letter, and return it to ICU Medical.
• Contact ICU Customer Care at (866) 829-9025 and select option 8, for a Return Goods Authorization. Customers may also E-mail: recall@icumed.com
• Customers will be credited for any returned product.

About Class I Recalls

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.