Events

Retiro De Equipo (Recall) de Posey Connecting Straps & Belts/Locking Cuffs.

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 J T Posey Company.

¿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
    Recall
  • ID del evento
    50134
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0934-2009
  • Fecha de inicio del evento
    2008-09-08
  • Fecha de publicación del evento
    2009-02-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74796
  • 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
    Restraint, protective - Product Code FMQ
  • Causa
    The recall was initiated after an investigation conducted by the posey company determined that a patient may be able to catch the belt on a stationary object (wall, pipe, etc.) and use their body force to tear or break the strap, creating freedom of arm movement. in some patient populations, such freedom of movement could pose an unwanted hazard of serious injury to a patient or caregiver.
  • Acción
    An "Urgent Medical Device Recall (Correction)" letter dated August 15, 2008 was mailed via US Postal Service to affected customers. The letter described the issue, instructed customers to secure a replacement label with the correct application technique over the picture in the 2008 Posey Catalog and provided a corrected Posey Locking Cuffs Instruction Sheet (19273). The Posey Company also provided updated literature for the Posey Locking and Non-Locking Connecting Straps 19270 and 19254. The Posey Company asked customers to complete and return the "Reply Fax-Back Acknowledgment" Form via fax (626-443-5418) or e-mail (vcimmarusti@posey.com) within 7 days. Contact your Sales Representative with any questions or concerns.

Device

Posey Connecting Straps & Belts/Locking Cuffs.
  • Modelo / Serial
    Catalog Numbers: 2320, 2330, 2346, 2350, 2351, 2355, 2360, 2208, 2209, 2210, 2211, 2212 and 2213.
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution including USA and countries of Australia, Belgium, Canada, France, Germany, Ireland, Italy, Korea, Lithuania and Netherlands.
  • Descripción del producto
    Posey Connecting Straps & Belts/Locking Cuffs. || The device is used to limit the wearer's movement by securing cuffs to a connecting strap or belt.
  • Manufacturer
    J T Posey Company

Manufacturer

J T Posey Company
  • Dirección del fabricante
    J T Posey Company, 5635 Peck Rd, Arcadia CA 91006
  • Empresa matriz del fabricante (2017)
    Tidi Products Llc
  • Source
    USFDA