Chemical Indicator 3M Comply OE 1251. Lots under risk: 2008-02AA, 2008-03AA, 2008-04AA, 2008-05AA, 2008-08AA, 2008-10AA, 2008-10AB, 2008-12AA, 2009-02AA, 2009-02AB , 2009-04AA, 2009-05AA, 2009-08AA and 2009-09AA. Product exempted from registration with the Ministry of Health. 의 안전성 경고

Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.

In a routine test conducted by 3M Health Care, a small discrepancy in the production specification was identified in the visual color change of the test strip: while the product label determines that the green color means adequate exposure to ethylene oxide, the product specification allows several color tones - which can also be interpreted as green - to indicate inadequate exposure to Ethylene Oxide. Thus, in cases of inadequate sterilization cycles (with ethylene oxide), false positive results may occur - the tape may be green when it should be red, according to the product label. Such a situation may lead users to incorrectly conclude that the sterilization cycle was adequate. The company 3M do Brasil Ltda reported that it has already sent a letter of communication to the customers involved, with an attached response form, and has already started the procedure for collecting the batches under risk of the product in Brazil. The company also announced that it intends to finalize the collection and replacement of the products until 05/30/2008. Anvisa's Technovigilance Unit is monitoring this case.