FDA-Device2014-07-16Class II
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
3M Company - Health Care Business
Hazard
Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product contains dry natural rubber" as required by the United States Food and Drug Administration (FDA) for medical devices. The non-slip pads at the bottom of the unit contain dry natural rubber. One incident of an allergic reaction in a sensitized individual has been reported.
Sold states
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRALIA, CANADA, CHILE , COLOMBIA, COSTA RICA, SOUTH AFRICA, BRAZIL, GERMANY, ECUADOR, DUBAI, JAPAN, HONG KONG , CHINA, KOREA, MALAYSIA, PANAMA, SINGAPORE, VATICAN, and THAILAND.
Affected count
5343 (2621 USA, 2722 OUS)
Manufactured in
3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul, MN, United States
Products
3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2002-2014Don't want to check this manually?
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