Alerta De Seguridad para Butterfly Vacuette Saf.Blood Collec.Set w / Adap. Luer 21G (450081) and 23G (450082) - Anvisa Record 10290310033 - Lots Affected: Item: 450081I - Lots: 12I25 / 12H23 - Item: 450082I - Lots: 12I14 / 12H28.

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.

According to the Risk Analysis Report of this product, the problem can be detected visually by the healthcare professional. Leakage through the luer adapter does not create risk to the patient, but is related to the safety of other people due to the risk of contamination, such as the user. However, this risk is greatly reduced by the use of disposable gloves by the health professional in all stages where there is a possibility of contact with biological material, as recommended in the General Guidelines for Containment Work with Biological Material of the Ministry of Health and in regulations in force on biosafety, such as RDC 11/2012 which provides for the operation of analytical laboratories that carry out analyzes on products subject to Sanitary Surveillance, RDC 302/05, which provides for Technical Regulation for the operation of Clinical Laboratories, NR32, which deals with Safety and Health in Work in Health Services, among others. UPDATED 08/01/2014 - The company finalized the field action and the units collected were destroyed.