Medical Devices
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Alerts and Notices (Devices)
Problems with medical devices may be caused when devices malfunction. But problems also may arise when users--either health professionals or the general public--do not understand or follow proper use instructions. FDA issues alerts and warnings to explain why problems may be occuring and clarify proper procedures to ensure safe and effective use of devices.
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Boston Scientific Medical Devices Stolen
Notification: Non-Sterile Boston Scientific Devices Stolen
A non-sterile shipment of Boston Scientific's medical devices used in endoscopy and urology was stolen between April 8, 2011 and April 11, 2011. Since they were stolen prior to being sterilized, use of these non-sterile devices may lead to infection.
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Contact FDA
1-800-638-2041
301-796-7100
Fax:301-847-8149
CDRH-Division of Small Manufacturers, International and Consumer Assistance (DSMICA)
Office of Communication, Education and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue
WO66-4621
Silver Spring, MD 20993
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