Events

Safety Alert for Infusion pumps, syringe type, Freedom60 hose assemblies 2 mL / hr used with Freedom60 Infusion Pump Syringes Catalog number F2ML; lot number 1.300 / 00

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Repro-Med Systems Inc/Gyneco 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
    309
  • Date
    2001-10-12
  • 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 hose assemblies above may separate from the female luer connector. the manufacturer initiated removal by telephone dated april 19, 2001, requesting the return of affected products.
  • Action
    Verify receipt of Repro-Med Systems telephone dated April 19, 2001. Identify and isolate all affected products in inventory. For more information, contact your local representative or directly with Repro-Med at 1 (845) 469-2042 (in the United States).

Device

Infusion pumps, syringe type, Freedom60 hose assemblies 2 mL / hr used with Freedom60 Infusion Pu...

Manufacturer

Repro-Med Systems Inc/Gyneco Inc
  • Source
    ANVSANVISA