Events

Safety Alert for MULTIPACK FOR OPTISTAR MR - Registration 80136710130 - VAZ Syringe 60ml - AFFECTED LOTS: 0130214; 0278106; 1021271; 9212120; 9260020; 9302042. MULTIPACK FOR OPTISTAR LE - Registration 80136710127 - VAZ Syringe 60ml - AFFECTED LOTS: 0008414; 0008415; 0029500; 0067043; 0078240; 0155153; 0155154; 0162123; 0235010; 0235011; 0246197; 0300142; 1007201; 1021246; 1028229; 1028232; 1035287; 1049313; 1056021; 1063220; 1070128; 1091217; 1098211; 1105219; 1147187; 1238134; 9037138; 9037139; 9058256; 9100261; 9114151; 9128089; 9163187; 9176144; 9247098; 9275102; 9310048; 9317055; 9331149; 9338345.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MALLINCKRODT DO 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
    1117
  • Date
    2012-03-05
  • 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
    The occurrence has been identified in Japan. No known adverse events are known. There are no records in NOTIVISA. Anvisa will follow this action. #### UPDATE (09/25/2012): In a field action monitoring report, the company reported that it has collected, so far, 48,304 units of the product at risk (out of a total of 654,399 units sold in Brazil. ## CONCLUSION OF THE FIELD ACTION: According to the Field Action Completion Report (exp 0157288 / 13-1) presented by the registry holder, of the 315 clients contacted, 92 (29.2%) reported the quantity of products to be returned or consumed, and 233 did not respond.He collected 48,452 (9.5%) units, out of a total of 509,246 units sold in Brazil.The stock was closed by the company on 02.22.2013.
  • Reason
    Sterilized packages of these devices were identified that were not sealed.
  • Action
    Identify the affected products in stock, immediately discontinue use, segregate products, and complete the Customer Return Form for return.

Device

MULTIPACK FOR OPTISTAR MR - Registration 80136710130 - VAZ Syringe 60ml - AFFECTED LOTS: 0130214;...

Manufacturer

MALLINCKRODT DO BRASIL LTDA.