안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.
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.
데이터 추가 비고
According to the manifestation of the company, in compliance with RDC 23/2012, the deviation verified was punctual, there being no risk to consumer health because it is a visible deviation. Should any customer still identify any units in their inventory, please contact the company to arrange for the collection of the product by e-mail sac2@laborimport.com.br or sac@laborimport.com.br
원인
According to the report of analysis nº 2384.00 / 2014, issued by the adolfo lutz institute, the safety jet 5ml safety syringe product, date of manufacture 01/2010, val 01/2015, lot 100120, was considered unsatisfactory in the aspect test .
조치
The Sanitary Vigilance of the Municipality of São Paulo determined the interdiction and collection, by means of publication in the Official Gazette of the City of São Paulo on 09/23/2014 page 57, COVISA Communiqué No. 70/2014.