Safety Alert for SYRINGES COMPLETED WITH HEPARIN (Anvisa Registration No. 80102510411). List of Affected Lots available at: http://portal.anvisa.gov.br/wps/wcm/connect/7a2e4b004b9d159eb232b2af8fded4db/List+of+boats+faved+-World+.pdf?MOD=AJPERES.

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.

Tests performed by the manufacturer on product samples withheld at the company indicated the loss of heparin potency - some batches failed in the Anti-Factor IIa potency assay. Based on the result of these tests and the fact that these syringes did not meet the requirement of the USP monograph on "power", the manufacturer chose to collect all syringes from the affected lots. In Brazil, the company VR Medical Ltda reported that UTVIG has already initiated the product recall action - according to the company, 135,628 units of the affected product were imported into Brazil, of which 72,793 units have already been sold and 62,835 are in stock. # Update (08/20/2012): The company sent a report of completion of the corrective action to the UTVIG, stating that it had collected / segregated its inventory and destroyed 74,472 product units. Attached to the same document (report of completion of the field action), are the reports of destruction of the products.