Events

Safety Alert for (1) CUSTOM SETS OF THE HEART-LUNG EXTRACORPHORUS PERFUSION UNIT; (2) PERSONALIZED STEREO SETS OF THE HEART-LUNG EXTRACORPHORUS PERFUSION UNIT; (3) STEREO VOLUME LINES OF EXPURGO. Lots: (1) 04F0186, 05F0004, 06F0005, 06F0151, 06F0159, 06F0165, 06F0168, 06F0189, 06F0193, 06F0248, 06F0255, 06F0300, 06F0323, 06F0347, 06F0379, 07F0003, 07F0017, 07F0038, 07F0081, 07F0094, 07F0100 , 07F0185, 08F0006, 08F0006, 08F0018, 08F0036, 08F0082, 08F0194, 08F0194, 08F0194, 08F0253, 08F0256, 08F0258, 08F0265, 08F0288, 08F0346, 08F0348, 08F0375, 08F0386, 09F0002, 09F0117 THROUGH 09F0119, 09F0195, 09F0212, 09F0251, 09F0261 , 09F0265, 09F0265, 09F0266, 09F0266, 09F0269, 10F0011, 10F0290, 10F0294, 10F0323, 10F0328, 10F0341, 10F0353, 10F0362, 10F0264, 10F0264, 10F0260, 10F0276, 10F0286, 10F0212 , 10F0368, 10F0369, 10F0369, 10F0389, 10F0389, 10F0392, 10F0428, 10F0453, 10F0460, 10F0461, 10F0464, 11F0003, 11F0024, 11F0030, 11F0098, 11F0099, 11F0111, 10F0115, 11F0163, 11F0210, 11F0214; (2) 06F0862MP, 08F0827MP, 08F0832MP, 09F0832MP, 09F0850MP, 09F0852MP; (3) 06F0600.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by COBE CARDIOVASCULAR INC. DIV SORIN BIOMEDICAL INC.

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
    57
  • Date
    2001-04-27
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    The plastic valve of a single direction of the exterior blood line of these sets may break. the manufacturer began a removal for a letter sent on november 6, 2000.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE LETTER SENT ON NOVEMBER 6, 2000. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. FOR FURTHER INFORMATION CONTACT YOUR CARDIOVASCULAR REPRESENTATIVE OR COBE ON PHONE 0021-1-880-221-7943.

Device

(1) CUSTOM SETS OF THE HEART-LUNG EXTRACORPHORUS PERFUSION UNIT; (2) PERSONALIZED STEREO SETS OF ...

Manufacturer

COBE CARDIOVASCULAR INC. DIV SORIN BIOMEDICAL INC
  • Source
    ANVSANVISA