Events

Safety Alert for WARMING MITTS AND SEALS: (1) HYPOTHERMAL RESCUE (THERMAL RESCUE HYPOTHERMIA), (2) THERMO-STAT HYPOTHERMIA (THERMO-STAT HYPOTHERMIA). WE. CATALOG: (1) TR 04004 / ETR-04004, 06-003 / 1T0311; (2) 10-1005 / 1T0310; ALL LOT NUMBERS

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

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
    160
  • Date
    2000-04-12
  • 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
    Water may evaporate from polyvinyl chloride bag on the heating gloves mentioned after long storage periods. this evaporation results in an increase in salt concentrations, which could increase the temperature of the sleeve and cause burns in the patient. aquarius medical has not received any complaint or report of injury caused by use of the above gloves mentioned. the manufacturer started a removal by correspondence dated 12 april 2000.
  • Action
    MAKE SURE THAT YOU HAVE RECEIVED THE CORRESPONDENCE OF 12 APRIL 2000 AND THE AQUARIUS MEDICAL PRODUCTION INFORMATION FORM. IDENTIFY AND ISOLE ANY PRODUCT AFFECTED FROM YOUR INVENTORY. DISCLAIMS THE USE AND DISTRIBUTION OF ANY DEFECTIVE PRODUCT, CONSIDER IT TO BE USED AND DESTRUCTES IT IN ACCORDANCE WITH APPLICABLE LAWS, REGULATIONS AND DECREES, FEDERAL, STATE AND LOCAL. PLEASE FILL OUT THE PRODUCTION INFORMATION FORM AND SEND TO AQUARIUS MEDICAL BY MAIL AT THE ABOVE ADDRESS OR BY FAX AT 1 (480) 991-4335. IF YOU PREFER TO RETURN THE DEFECTIVE PRODUCT, CONTACT YOUR LOCAL REPRESENTATIVE OR DIRECTLY WITH AQUARIUS MEDICAL BY PHONE 1 (480) 991-1818 TO RETURNED GOODS AUTHORIZATION NUMBER. FOR FURTHER INFORMATION, PLEASE CONTACT CHRISTINA FLEMING, AQUARIUS MEDICAL, BY PHONE1 (480) 991-1818, RAMAL 219.

Device

WARMING MITTS AND SEALS: (1) HYPOTHERMAL RESCUE (THERMAL RESCUE HYPOTHERMIA), (2) THERMO-STAT HYP...

Manufacturer

AQUARIUS MEDICAL CORP
  • Source
    ANVSANVISA