Events

Alerta De Seguridad para Hospital Gas Cylinders with Gas Cylinder Valves Model CGA-580 Sherwood. Lots Nos .: 03-00, 43-99, 48-99; Connector No. CGA 580

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Kendall Healthcare Products Co A Tyco Healthcare Group Co.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    227
  • Fecha
    2000-12-15
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Causa
    Airgas has been informed that the hospital gas cylinder valves of the aforementioned lots may have undergone too strong torque during assembly, resulting in damage to the threads. failures have been reported during filling of the cylinders with the aforementioned valves, and it is suspected that such failures may also occur during the provision of system pressurizing service. airgas declares that these failures have resulted in the separation of the valve protection registers and caps, strong enough to potentially cause serious injuries and property damage.
  • Acción
    Airgas recommends the following: (1) Check valves on all gas cylinders containing argon, helium, nitrogen and non-flammable gas mixtures, or any other cylinders equipped with defective valves. (2) If any cylinder is from Airgas, isolate the cylinders and identify them with a mark or label. (3) Contact your local representative or directly with Judy McCurry, Airgas, at 1 (916) 376-8515, ext. 2344, for them to be collected and replaced. (4) If a cylinder is connected to a pressurized system, with or without the valve opening, do not touch the cylinder or valve because the valve cap may be ejected. Isolate the area and contact your local representative or directly with Airgas, or your local supplier for assistance. For more information, contact Judy McCurry, Airgas, Correspondence at the above address, or call 1 (916) 376-8515, ext. 2344. ECRI notes that these cylinders may be used by hospital personnel for refrigeration, diagnostic imaging by magnetic resonance, medical and vacuum gas maintenance systems.

Device

Hospital Gas Cylinders with Gas Cylinder Valves Model CGA-580 Sherwood. Lots Nos .: 03-00, 43-99,...

Manufacturer

Kendall Healthcare Products Co A Tyco Healthcare Group Co
  • Source
    ANVSANVISA