Events

Retiro De Equipo (Recall) de 1100 Series Aluminum Retractors

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 Lone Star Medical Products, Inc.

¿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
    36592
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0213-2007
  • Fecha de inicio del evento
    2004-10-06
  • Fecha de publicación del evento
    2006-11-28
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2006-12-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49002
  • 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
    Retractors - Product Code GAD
  • Causa
    Ni-cr plated 1100 series retractors with a chromium finish were replaced by retractors with a hard-anodized finish after complaints of peeling were received.
  • Acción
    For domestic customers, the firm sent product replacement letters to customers (as listed on the firm's invoices), and hospital operating room personnel on October 6, 2004. On November 8, 2004, a faxed letter was sent to the Purchasing/Materials Management Department of all customers. From November 9 through November 12, 2004, a phone call drive was conducted to contact appropriate individuals for each customer. For international customers, the firm notified distributors and obtained end user details from them. End users were then contacted and communicated with regarding the product replacement. In addition, the firm utilized its Summer and Fall 2004 newsletters to communicate the product replacement information. Customers were encouraged to return NiCr coated products for a hard-anodized coated replacement product.

Device

1100 Series Aluminum Retractors
  • Modelo / Serial
    Lot #5869 (Serial numbers: 5193 thru 5200, 5207 thru 5211 and 5213 thru 5229); Lot #5924 (Serial numbers: 5244, 5245, 5254, 5256 thru 5260, 5169, 5172, 5181, 5152, and 5185 thru 5187); & Lot #5982 (Serial numbers: 5148, 5176, 5183, 5184, 5188, 5192, 5204, 5206, 5253 and 5255).  Serial numbers: , ;
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    World wide, including USA, Denmark, Germany, Finland, France, Taiwan, Canada, South Korea, New Zealand, Hong Kong, Italy, England, Australia, Saudi Arabia, South Africa and Singapore.
  • Descripción del producto
    Lone Star Medical Products, Inc. 1100 Series Aluminum Retractor Rings, Model #1107; manufactured by Lone Star Medical Products, Inc.
  • Manufacturer
    Lone Star Medical Products, Inc

Manufacturer

Lone Star Medical Products, Inc
  • Dirección del fabricante
    Lone Star Medical Products, Inc, 11211 Cash Rd, Stafford TX 77477
  • Source
    USFDA