use of the products included in the recall may cause serious injuries or death
San Diego, CA (PRWEB) October 16, 2014
AttorneyOne.com, a recognized authority on law, updates the website daily regarding all the latest information from the FDA on Stat2 Flow Controller.
The FDA announced on October 10 that the ICU Medical ConMed Stat2 Flow Controller is recalled because it was assembled with the wrong internal component and it may deliver fluid at a much higher flow rate than what is set. IV administration sets are used for the delivery or removal of fluids from the body; a flow controller controls the amount of fluid delivered.
The affected item numbers are: 011-C9801, 011-C9802, AH7007, B9897, Z2648 and affected lot numbers are: 2768416, 2768417, 2758229, 2785379, 2801951, 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL. Their manufacture dates were from October, 2013 to January, 2014 and their distribution dates from October 2013 to January 2014. The FDA classified this recall as Class I, meaning use of the products included in the recall may cause serious injuries or death.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds “We are determined to keep an eye on FDA announcements concerning Stat2 Flow Controller and inform the public. For that reason," he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
As the FDA notes, “On August 19, 2014, ICU Medical Inc. sent an Urgent Medical Device Recall Notification letter to affected customers and authorized distributors.” And the Agency adds, “The letter identified the affected product, problem and actions to be taken. The letter advised customers to remove the affected devices from use and return them to ICU Medical, Inc.”
AttorneyOne.com has further information on Stat2 Flow Controller at the website including the latest major drug, food, and medical products law news.
Headquartered in San Diego, CA, Attorney One was founded in 2004 and is not a law firm. They offer a nationwide legal service which helps consumers find the best representation for their legal needs. You can learn more about Attorney One at our website http://www.attorneyone.com. You can also find us on Facebook at http://www.facebook.com/AttorneyOne. Checkout earlier news from us at http://www.prweb.com/releases/2014/09/prweb12248057.htm