Events

Retiro De Equipo (Recall) de Device Recall ONQ Silver Dressing

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 Acrymed Incorporated.

¿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
    60192
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0306-2012
  • Fecha de inicio del evento
    2008-06-30
  • Fecha de publicación del evento
    2011-11-29
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-20
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104716
  • 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
    Dressing, wound, drug - Product Code FRO
  • Causa
    The silver dressing, lot h0705j and h0706j may contain dressings that are not properly sealed in the foil pouch, which could affect sterility of the dressing.
  • Acción
    On June 30 2008, the firm e-mailed all affected customers with an Important Product Recall Notification letter. The customers were notified that two lots of SilverDressing may contain dressings that are not properly seated in the foil pouch. The customers were instructed to inspect the inventory, ceased distribution of the affected lots and quaratine the remaining inventory and notify AcryMed. Customers can call AcryMed at 503-624-9830 for any questions about this recall.

Device

Device Recall ONQ Silver Dressing
  • Modelo / Serial
    Lot Numbers: H0705J (I-Flow Lots 17055 and 17054) and H0706J (I-Flow Lot 17054). Expiration date: 11/1/2008.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    Unclassified
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution -- DE, FL, KY, OR, IN, TX, NV, MT, CA and NY.
  • Descripción del producto
    ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapped in a foil pouch. Each pouch contains 1 single use 4" x 4.5" pad. There are 5 pouches per box. Ref: SD4X4.5; Part Number: IF-151023 and IF-151026. || The product is labeled in parts: "***5 DRESSINGS***4 X 4.5 INCHES***REF SD4X4.5***PART NO. 5001826***ON-Q SilverDressing is a silver containing adhesive transparent polyurethane film for fixation and securement of devices to the skin as a primary contact sound dressing***MANUFACTURED BY ACRYMED***DISTRIBUTED BY I-FLOW***AcryMed, Inc Beaverton, OR 97008***". || Intended for use in securing devices such as catheters to the skin. Also intended for use as a primary or secondary cover wound dressing on surgical incision sites.
  • Manufacturer
    Acrymed Incorporated

Manufacturer

Acrymed Incorporated
  • Dirección del fabricante
    Acrymed Incorporated, 9650 SW Nimbus Ave, Beaverton OR 97008-7171
  • Source
    USFDA