Events

Safety Alert for Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL ST01: 71HF30DB00, 71HF30DB00, 71HF30D00, 71HF30DD00, 71HF30DD00, 71HH19DA00, 71HH19D0000, 71HH19D0000, 71HH19DD00, 71HI05DA00, 71HI05DB00, 71HI12DA00, 71HI09DA00, 71HI11DA00, 71HI15DA00, 71HI12DA00, 71HI16DA00, 71HI17DA00, 71HI18DA00, 71HI19DA00 -. b) TYPE VL ST02: 71HE31DF00, 71HE29DA00, 71HE31DF00, 71HE29DB00, 71HE30DA00, 71HE30DB00, 71HE30DC00, 71HE31DA00, 71HE31DB00, 71HE31DC00, 71HE31DD00, 71HG15DA00, 71HG15DC00, 71HG15DB00, 71HG15DB00, 71HG15DC00, 71HG17DA00, 71HG15DD00, 71HG17DB00, 71HG22DC00, 71HG22DD00, 71HG15DD00, 71HG17DA00, 71HG22DC00, 71HH19DI00, 71HH19DK00, 71HH21DB00, 71HH21DC00, 71HH26DC00.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Fresenius Hemocare Brasil Ltda..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    1447
  • Date
    2014-10-17
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the data
    According to the company, the divergence in information does not risk the patient, considering that the product is in fact free of DEHP. The divergence of information is in the place of symbols. The DEHP free information is correctly described on the label. The company also informs that this product is of exclusive use for pump of infusion and restricted to the hospital scope. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Reason
    The company informs that an error was identified in the labeling of the product. the product is exempt from dehp, and this information appears on the label, i do not understand in the area where the symbols of "barren, single-use product, keep out of moisture, among others" were misprinted, the symbol "contains dehp ". the difference in the contains and does not contain deph symbol is only a transverse trait.
  • Action
    The company forwarded communication to customers who have already received the product stating the error.

Device

Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL S...

Manufacturer

Fresenius Hemocare Brasil Ltda.