Alerta De Seguridad para BD Vacutainer Glass Tubes with Vacuum Blood Collection Reagents Technical Name: BOTTLE OR MATERIAL FOR COLLECTION, STORAGE OR TRANSPORTATION OF BIOLOGICAL SAMPLES ANVISA Registration Number: 10033430467 Hazard Class: I Affected Model: VACUTAINER TUBE CITRATE .105 M TAMPA HEMOGARD 4.5 ML Serial numbers affected: Lots: 5336909; 5357632; 6,040,953; 6064634; 6124932; 6173983; 6187600

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.

The letter was forwarded to customers who purchased the affected lots and advises users to: "Be sure to use Personal Protective Equipment (EPI) in accordance with instructions for use of the product, such as protective gloves and waterproof clothing, during and after The collection of any additional equipment required to ensure a safe collection, such as protective masks, should be considered; It is recommended to hold the tube while it is in the holder during collection. blood with BD Vacutainer® Push Button or BD Vacutainer® Safety-Lok ™ venipuncture safety device, the tube must be held while it is in the holder and held with the cap positioned up until the blood collection is completed. In addition, BD provided free letter service on 0800 055 5654 and e-mail consultor_vacutainer@bd.com in order to clarify any possible doubts to its customers.