Events

Safety Alert for OXYGEN BRASS REGULATORS PRECISION MEDICAL EASY DIAL: (1) MODEL 168704DLB, (2) MODEL 168708DB, (3) MODEL 168708DLB, (4) MODEL 168715DB, (5) MODEL 168715DLB, (6) MODEL 168725DB. LOTS / DATE CODES: (1 THROUGH 6) 0999 À 0401 BODY STAMPS NEAR METAL ENTRY

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by PRECISION MEDICAL 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
    58
  • 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 boards of these regulators were modified to reduce weight. these modifications allowed a user, without wishing, to place the regulator in the nitrogen valve position. the manufacturer began removal by a letter sent on april 24, 2001.
  • Action
    VERIFY THAT YOU HAVE RECEIVED THE PRECISION MEDICAL LETTER OF APRIL 24, 2001 .. IDENTIFY AND ISOLE ANY OF THESE PRODUCTS THAT ARE IN YOUR INVENTORY. PRECISION MEDICAL ENSURES THAT ALL PRODUCTS RETURNED WILL BE REPLACED FREE OF CHARGE. TO RECEIVE THE RETURN AUTHORIZATION FORM CONTACT THE REMOVAL COORDINATOR BY E-MAIL REGULATOR@PRECISIONMEDICAL.COM OR BY PHONE 0021-1-610-262-6090. PRECISION MEDICAL REQUESTS YOUR NAME, ADDRESS, PHONE NUMBER AND CONTACT NAME, AND THE NUMBER OF REGULATORS TO BE REPLACED IN ORDER TO ISSUE THE RETURN AUTHORIZATION NUMBER. FOR FURTHER INFORMATION CONTACT YOUR REPRESENTATIVE OR MEDICAL PRECISION BY PHONE 0021-1-610-262-6090.

Device

OXYGEN BRASS REGULATORS PRECISION MEDICAL EASY DIAL: (1) MODEL 168704DLB, (2) MODEL 168708DB, (3)...

Manufacturer

PRECISION MEDICAL INC
  • Source
    ANVSANVISA