Wrong Internal Component Leads to Class I Recall of ConMed Stat2 Flow ControllerOct 13, 2014
The U.S. Food and Drug Administration (FDA) has announced that ICU Medical, Inc. issued a recall for its ConMed Stat2 Flow Controller. The FDA deemed the recall a Class I, the agency’s most serious recall designation.
ICU Medical Inc. is recalling the Stat2 Flow Controller over an assembly issue. The device was assembled with a wrong internal component, which means that the Flow Controller may deliver fluid at a much higher flow rate than for what it was set. The recalled device is used with IV administration sets containing hypodermic needles and tubing. The ConMed Stat2 Flow Controller is used to deliver or remove fluids from the body, in humans or animals. The amount of fluid delivered is controlled by a flow controller.
An FDA Class I designation means that use of the affected product may cause serious adverse health consequences, including death.
The recall date is August 19, 2014 and involves the ConMed Stat2 Flow Controller, which is used in intravenous (IV) administration sets. The recalled devices were manufactured from October 2013 through January 2014 and were also distributed during this time.
The item numbers involved are:
The impacted lot numbers are:
On August 19, 2014, ICU Medical Inc. issued an Urgent Medical Device Recall Notification letter to affected customers and authorized distributors. The letter identified the affected, recalled product; the problem with the device; and the actions to be taken. The letter advises customers to:
- Remove the affected ICU Medical, Inc.’s ConMed Stat2 Flow Controller devices from use and to return the recalled device to ICU Medical, Inc.
- Complete sections A and B of the Recall Response Form included with the letter and to return the completed form 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: firstname.lastname@example.org.
Customers will be credited for any returned product.