CONTOUR MICROPARTICLES OF PVA FOR EMBOLIZATION - Registered in Anvisa under the number 10341350316. Lots - Attached List. 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.

Attached to this notification is a complete listing of all product codes within the scope of this Voluntary Collection. The company is aware that some customers can often remove the product from their carton (secondary packaging) and store it on the stock shelves only in their primary packaging (pouch). If this is a practice in your unit, it is very important that you use the attached product table very carefully, and consider both the UPN code on the primary packaging (pouch) and the secondary packaging (box) when looking for the affected product / product of this voluntary recall, since the UPN numbers on the internal and external labels are different. The product information listed on your Verification and Traceability Response Form (attached in this alert) provides only the UPN codes of the secondary packaging (carton). Anvisa is following this action.