Retiro De Equipo (Recall) de Device Recall Cardinal Health BLUE IMPERVIOUS GOWN WITH THUMBHOOKS

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cardinal Health.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Non-surgical isolation gown - Product Code OEA
  • Causa
    Blue impervious gown with thumbhooks, x-large. all lots do not meet design specifications, specifically 16 cfr 1611 - standard for the flammability of vinyl plastic film. the standard defines a specific test method that quantifies the rate of flame propagation against a minimum value using an engineered test fixture. the method requires that the test be performed on different orientations of the film (machine direction and cross direction). the machine direction is defined by the manufacturing process generating the film. the formed film exits the machine moving in the machine direction. the cross direction is at 90 degrees to the machine direction. the more rapid burning direction defines the results of the test (either a pass or fail). the products being recalled failed when tested in the machine direction with a result of 1.9-2.0 inches/second versus a limit of 1.2 inches/second. they passed by self-extinguishing when tested in the cross direction.
  • Acción
    The firm sent an URGENT: PRODUCT RECALL dated 7/20/2016 describing the reason for the recall. The letter also provides instructions for the user on how to address this issue. Cardinal Health anticipates replacement inventory of 5213PG will be available by August 22, 2016 and V5213PG by August 29. Until that time, the recommended substitute product is 5210PG, which shares all the design characteristics of 5213PG (blue polyethylene film material, over-the-head donning/tear-away removal, half-back, thumb hook wrists) and comes in similar packaging (15 individually packed gowns per box, 5 boxes per case for a total of 75 gowns per case). The firm advises that the 5210PG is "Universal" size, which is smaller than 5213PG (XL size), so it may not work for all users. The firm is requesting all customers to take the following actions: 1. Immediately stop distributing affected product. 2. Return the enclosed acknowledgment form via fax to 847.689.9101, whether or not they have affected product, as Cardinal Health is required to confirm receipt of this notification. 3. Contact the Distributor Management Customer Service team at 800.635.6021 to arrange for credit and return of any affected product they may have. 4. Customers do not need to notify any customers to whom they may have distributed product affected by this recall. If they have any questions relating to this recall, please contact Cardinal Health Customer Advocacy at 800.292.9332.


  • Modelo / Serial
    All Lots with material number 5213PG and V5213PG
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide to U.S. consignees located in the following states:AL ,AR ,AZ ,CA ,CT ,FL ,GA ,IL ,IN ,KY ,LA ,MA ,MD ,MI ,MO ,NC ,NJ ,NM ,NV ,NY ,OH ,PA ,SC ,TX ,UT ,VA ,WA and WV.
  • Descripción del producto
    BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown. Serves as physical barrier to the transfer of microorganisms, body fluids and particulate material. Level of barrier protection is nonspecific. || An isolation gown covers the torso and clothing and poses a physical barrier to the transfer of microorganisms, body fluids and particulate material
  • Manufacturer


  • Dirección del fabricante
    Cardinal Health, 1430 S Waukegan Rd, Waukegan IL 60085-6726
  • Empresa matriz del fabricante (2017)
  • Source