Events

Safety Alert for Hospital Gas Cylinders with Gas Cylinder Valves Model CGA-580 Sherwood. Lots Nos .: 03-00, 43-99, 48-99; Connector No. CGA 580

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Kendall Healthcare Products Co A Tyco Healthcare Group 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
    228
  • Date
    2000-12-15
  • 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
    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