Events

Safety Alert for TUBE CONNECTOR - Registration 80136710118. Presentation in Y 60 "COD 801106 - Lots Affected: 0029497; 0029497; 0064349; 0067042; 0288027; 0344214; 9135201; 9163184; 9191016; 9240130; 9247097 .. Presentation in Y 90" COD. 801107 - Lots Affected: 0029498; 0032077; 0081113; 0148235; 0225223; 0253258; 0273019; 0295181; 1014141; 1021230; 1028227; 1042218; 1042219; 1056020; 1070126; 1091205; 1098205; 1112018; 1196145; 9058254; 9058255; 9086222; 9170276; 9191018; 9345196; 9191019; 9212121; 9275100; 9295023; 9320079; 9327016; 9334064 .. 60BP CODE PRESENTATION. 601195: Lots Affected: 0036243; 0036246; 0043271; 0043272; 0043273; 0127197; 0127198; 0127199; 0169313; 0176210; 0218188; 0225131; 1217146; 9253015; 9253016; 9260008; 9260009; 9267041; 9288017; 9317025; 9295025; 9302040; 9320072; 9331141; 9338333; 9338334; 9357266. #### UPDATE - 03/29/2012 - COMPLEMENTATION OF LOTS Presentation 60BP CODE. 601195: 0246192; 0253140; 0295171; 0295172; 0305210; 0344201; 0363161; 0363163; 1014123; 1014124; 1021223; 1021224; 1021225; 1021226; 1021227; 1035293; 1049306; 1084119; 1217145; 1224133. ####

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
    1118
  • 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.
  • Reason
    Sterilized packages of these extensors 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

TUBE CONNECTOR - Registration 80136710118. Presentation in Y 60 "COD 801106 - Lots Affected: 0029...

Manufacturer

MALLINCKRODT DO BRASIL LTDA.