Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated
MedSun: Newsletter #24, May 2008

The recent serious injuries and deaths associated with the use of potentially contaminated heparin are very much in focus at this time. To the MedSun Community: Your reports submitted to MedSun are key to MedSun's success in helping FDA and the manufacturers ensure the safety of medical devices, tissues, cells, and related products, so please report the problems you see. The information from incoming reports shared through MedSun News and the de-identified versions of the reports contributed to FDA’s public database benefit health care facilities and researchers throughout the Nation. You may still report these heparin issues though the MedSun system and rest assure they will be directed to the attention of the Center for Drug Evaluation and Research (CDER).

Additional Information:

Important Notice to Manufacturers and Initial Distributors of Medical Devices That May Contain Heparin Or Are Heparin-Coated. FDA Website. April 8, 2008.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm135345.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun