Events

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

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Kendall Healthcare Products Co A Tyco Healthcare Group Co.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    227
  • Date
    2000-12-15
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    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.
  • Action
    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