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U.S. Department of Health and Human Services

Medical Devices

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Update to FDA Public Health Notice Radioactivity in Radiation Protection Devices

This is an archived document and is no longer current information.

FOLLOW-UP TO FDA PUBLIC HEALTH NOTICE DATED June 13, 1997,
AND ENTITLED "RADIOACTIVITY IN RADIATION PROTECTION DEVICES"

FDA continues its investigation into the issue of radiation protection devices contaminated with lead-210 (Pb-210) and its daughter nuclides bismuth-210 (Bi-210) and polonium-210 (Po-210). E-Z-EM of Portchester, NY, including products labeled from Picker Corporation of Cleveland, OH, have issued a voluntary recall for affected personal protective equipment such as thyroid shields and lead aprons. On July 24, 1997, the Agency classified this voluntary action as a Class II recall.

It is FDA's understanding that Wolf X-ray of W. Hempstead, NY, has indicated it is instituting a voluntary recall for affected products it manufactured after October 1996. Other medical device manufacturers who may be involved in this issue are still under investigation.

Because the type of devices manufactured from the contaminated lead varies from lot to lot, we are not able to provide specific information for each manufacturer and device. You may wish to contact the manufacturer of the device in question for this information. Please be aware that not all devices from a particular manufacturer are in question, only those containing the contaminated lead. Additional information on recall of this product and other recalls.  We will continue to keep you updated via FDA's internet site as information becomes available.

 

If you have questions about this Notification, please contact FDA's  Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at dsmica@fda.hhs.gov or by phone at 1-800-638-2041 or 301-796-7100