ICU Medical’s ConMed Stat2 Flow Controller was recalled 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.
Intravenous (IV) administration sets contain hypodermic needles and tubing. They are used to deliver or remove fluids from the body. The amount of fluid delivered is controlled by a flow controller.
The affected IV flow controllers bare the item numbers 011-C9801, 011-C9802, AH7007, B9897, or Z2648. ICU Medical, Inc., of San Clemente, California, distributed the affected IV flow controllers between October 2013 and January 2014.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication