Events

Safety Alert for MicroJect Ambulatory Pumps: (1) Model 30 Continuous Low Flow, (2) Model 200 Intermittent or Continuous Flow. Reference Nos .: (1) 220039, (2) 220041; Nos. Ser.: (1) 37037 to 64215, (2) 40069 to 64008; all pumps were manufactured on 1 May 2000, on 19 November 2001.

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

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
    695
  • Date
    2003-03-07
  • 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
    Insufficient infusion and separation between the pump and the enclosure / protection box may occur with the ambulatory infusion pumps mentioned above. the manufacturer initiated a "recall" by letter dated august 23, 2002.
  • Action
    Make sure you received the letter from Sorenson Medical on August 23, 2002. Identify and isolate any affected product in your inventory. The manufacturer declares that it has implemented corrective actions to prevent a recurrence of the problem. Corrective action has been performed for MicroJet pumps distributed after August 23, 2002. For additional information, contact Sorenson Medical in the USA at (801) 352-1888. ANVISA has provided the Occurrence Notification Forms on the Internet http://www.anvisa.gov.br/sistec/notificacaoavulsa/notificacaoavulsa1.asp so that you notify if there are any problems with the products in your inventory. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485.

Device

MicroJect Ambulatory Pumps: (1) Model 30 Continuous Low Flow, (2) Model 200 Intermittent or Conti...

Manufacturer

Sorenson Medical
  • Source
    ANVSANVISA