Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall
Recall due to pocket fills may result in patient harm, serious injury, and/or death due to drug overdose or underdose.
PLEASE STUDY THE FOLLOWING SOURCE CAREFULLY:http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm243686.htm
Important notice:
The U.S. Food and Drug Administration (FDA) does not support or endorse this website. The information above was taken from the FDA's newsletter or RSS feed. If you are affected by a product alert, it is always essential to study the official sources carefully because FDA continuously updates the information as better information becomes available.
About FDA:
FDA is responsible for protecting the U.S. public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

















