Events

Retiro De Equipo (Recall) de Device Recall Monomid NonAbsorbable Suture

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 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
    59759
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3177-2011
  • Fecha de inicio del evento
    2011-06-29
  • Fecha de publicación del evento
    2011-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103603
  • 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
    Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
  • Causa
    Unapproved dye was used in manufacturing the non-absorbable blue nylon suture material.
  • Acción
    CP Medical sent a "RECALL NOTICE" letter dated June 29, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products in the human market and to return all their existing stock. A Recall Checklist was enclosed for customers to complete and return. Contact Customer Service at 1-800-950-2763 for a Return Good Authorization and shipping account number. The firm will pay for shipping cost and replace product at no cost to customers.

Device

Device Recall Monomid NonAbsorbable Suture
  • Modelo / Serial
    LOT Numbers: 070205-04, 070205-05, 070221-05, 070322-04, 070410-02, 070430-08, 070517-12, 070702-03, 070726-06, 070824-04, 070924-08, 071024-05, 080103-24, 080111-02, 080211-01, 080227-09, 080424-21, 080424-22, 080424-24, 080602-18, 080825-11, 080911-05, 081002-12, 081202-02, 090211-07, 090310-14, 090415-03, 090429-07, 090515-04, 090706-10, 090803-06, 090904-02, 091110-15, 091119-07, 100114-39, 100122-05, 100305-05, 100317-11, 100505-18, 100702-05, 100706-01, 100810-08, 100921-10, 101129-19, 101208-01, B0605230, D0510140, D0610330, D0611040, G0220310, G0619440, G0619530-1, H0523640, H0622330, J0528740, J0627630-1, J0628240, L0534830, and L0635430-1.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of Italy, Romania, South Africa, and Taiwan.
  • Descripción del producto
    Monomid Non-Absorbable Suture are blue, monofilament synthetic absorbable suture, with different sizes and different needle sizes. || The products are labeled in parts. || These sutures are intended for use in general soft tissue approximation and/or ligation including use in cardiovascular, ophthalmic, and neurological surgery.
  • Manufacturer
    C P Medical Inc.

Manufacturer

C P Medical Inc.
  • Dirección del fabricante
    C P Medical Inc., 803 NE 25th Avenue, Portland OR 97232-2304
  • Source
    USFDA