Events

Retiro De Equipo (Recall) de MonoDox Synthetic Absorbable Suture, Sterile

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 C P Medical.

¿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
    49599
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2582-2010
  • Fecha de inicio del evento
    2008-09-17
  • Fecha de publicación del evento
    2010-09-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-09-28
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73899
  • 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
    Absorbable Polydioxanone Surgical Suture - Product Code NEW
  • Causa
    Seal integrity of inner foil pouch of the mono-dox synthetic absorbable suture may be compromised.
  • Acción
    On 09/17/2008, the firm's Sale Representative began using the Telephone Script and calling all their customers. On 09/19/2008, the firm began sending the Recall Notice, dated 9/17/2008, letter to their customers. The letter states that the recalled product is Polydioxanone Suture, Code M397, Lot Number L0535440, Expiration Date: November 2009. The customers are advised to discontinue selling this product and return any existing stock to CP Medical. The firm also requests their consignees to notify their sub-accounts about this recall notice if the product is further distributed. The customers are instructed to provide return all accounted quantity and provide quantify information and location of any product that they are unable to recover for accountability purposes. Customers could contact CP Medical Customer Service Representative at 1-800-950-2763 for return goods authorization number and shipping account number.

Device

MonoDox Synthetic Absorbable Suture, Sterile
  • Modelo / Serial
    Lot number L0535440, EXP 2009-11.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US, Australia, and Taiwan.
  • Descripción del producto
    Product is labeled in part: "CP-SM397A-02...Mono-Dox Violet Monofilament Polydioxanone Synthetic Absorbable Sterile Suture. Do Not Resterilize.... 4/0 (1.5 metric) 30" (75cm) Rx Only...LOT L0535440 EXP 2009-11...4/0 M397A...Mono-Dox CUTTING NFS-2 NEEDLE...Manufactured by: CP Medical, Portland, OR USA". || Intended for use in general soft tissue approximation and/or ligation including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery.
  • Manufacturer
    C P Medical

Manufacturer

C P Medical
  • Dirección del fabricante
    C P Medical, 803 Ne 25th Ave, Portland OR 97232-2304
  • Empresa matriz del fabricante (2017)
    Juniper Holdings Inc.
  • Source
    USFDA