Update to FDA notice on radioactive lead

["Tupin, Edward A. 301-827-1230 Fax 594-4760" <EAT@CDRH.FDA.GOV>]

Here is the most recent update to the FDA Advisory notice on radioactive 
contamination in lead containing radiation protection devices.

Ed Tupin
RSO, Center for Devices and Radiological Health
Food and Drug Administration
EAT@cdrh.fda.gov
(301) 827-1230
Fax:  (301) 594-4760

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Update to FDA Public Health Notice Radioactivity in Radiation Protection 
Devices


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, can be obtained 
from http://www.fda.gov/opacom/Enforce.html 

We will continue to keep you updated via FDA's internet site as 
information becomes available.