Events

Safety Alert for REGULATORS 2-MODES OF CONTINUOUS VACUUM OHMEDA MEDICAL -: (1) MODEL 67XX-1225-9XX HOUSEHOLD STANDARD TEMPERATURE, (2) MODEL 67XX-1227-9XX LOW TEMPERATURE DOMESTIC PATTERN, (3) MODEL 67XX-1230- 9XX INTERNATIONAL ANTI-TIME SENTIMENT, (4) MODEL 67XX-1233-9XX INTERNATIONAL ANTI-TIME SENSE LOW, (5) MODEL 67XX-1330-9XX DOMESTIC STANDARD SENSE OF TIME HIGH. WE. SERIES GFHD 004234 À GFHD 053409.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by SQUIRE-COGSWELL/AEROS INSTRUMENTS; OHMEDA MEDICAL AN INSTRUMENTARIUM CO.

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
    77
  • Date
    2001-05-11
  • 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
    These regulators have incorrect labels. the correction was initiated by ohmeda with the letter sent on 4 and 10 october 2000.
  • Action
    VERIFY THAT YOU HAVE RECEIVED A LETTER FROM THE OHMEDA OF OCTOBER 2000. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. TO ORGANIZE THE RETURN OF THE PRODUCTS AFFECTED TO BE CONTACTED BY ITS REPRESENTATIVE OR EMILY DEMSKE, OHMEDA ON THE PHONE (410) 888-5200. FOR FURTHER INFORMATION, CONTACT SQUIRE-COGSWELL / AEROS INSTRUMENTS ON PHONE (847) 855-0800.

Device

REGULATORS 2-MODES OF CONTINUOUS VACUUM OHMEDA MEDICAL -: (1) MODEL 67XX-1225-9XX HOUSEHOLD STAND...

Manufacturer

SQUIRE-COGSWELL/AEROS INSTRUMENTS; OHMEDA MEDICAL AN INSTRUMENTARIUM CO
  • Source
    ANVSANVISA