Medtronic SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps and Sutureless Connector Intrathecal Catheter Products Recalled.
June 26, 2013 - MINNEAPOLIS – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
Products have been found to contain undeclared Sibutramine, known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Miami, Florida Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi” Weight Loss Supplement. These product have been found to contain undeclared Sibutramine, Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug.