Events

Retiro De Equipo (Recall) de Device Recall Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips

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 ASO, LLC.

¿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
    65819
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1890-2013
  • Fecha de inicio del evento
    2013-07-26
  • Fecha de publicación del evento
    2013-08-06
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-08-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120299
  • 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
    Closure, Wound, Adhesive - Product Code MGO
  • Causa
    This recall has been initiated by aspen surgical products, inc., due to the inability to confirm sterility.
  • Acción
    ASO sent a letter on July 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine your inventory and stop using/distributing the product. Place in quarantine to be returned or destroyed. ASO customers will receive credit for returned product or a returned completed Certificate of Destruction. Please use Return Authorization Number 1675 when returning the product. Please complete and return the enclosed response form as soon as possible. Return the form to: Address: ASO LLC Regulatory Affairs 300 Sarasota Center Blvd. Sarasota, FL 34240 Fax: 941-378-9040 Attn: Regulatory Affairs For questions regarding this recall call 888-364-7004, ext 146.

Device

Device Recall Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips
  • Modelo / Serial
    ASO Packaging Lot #s: 175770 and 209340
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.
  • Descripción del producto
    Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips || 30 strips 1/4 in. x 4 in. Sterile latex free || UPC # 639194043885 || Used to secure, close and support small cuts and wounds.
  • Manufacturer
    ASO, LLC

Manufacturer

ASO, LLC
  • Dirección del fabricante
    ASO, LLC, 300 Sarasota Center Blvd, Sarasota FL 34240-9381
  • Empresa matriz del fabricante (2017)
    Aso Corporation
  • Source
    USFDA