Events

Retiro De Equipo (Recall) de Monoswift

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
    68153
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1708-2014
  • Fecha de inicio del evento
    2014-04-23
  • Fecha de publicación del evento
    2014-06-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127056
  • 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, surgical, absorbable, polydioxanone - Product Code NEW
  • Causa
    Cp medical, inc., is recalling one lot of monoswift pgcl [poly (glycolide-co-caprolactone)] absorbable sutures for failing to meet the usp minimum average value for knot pull (tensile) strength.
  • Acción
    CP Medical, Inc., sent a Recall Notice letter dated April 28, 2014 to affected customers. The letter identified the affect product, problem and actions to be taken. The letter instructed customers to immediately discontinue selling or using the recalled product and return all existing stock to CP Medical. They also request their customers to contact downstream customers and request that all their existing stock be returned. CP Medical, Inc. asks all customers to provide them with information as to the quantity of recalled product they are able to return and for all stock they are not able to recover, customers are asked to provide quantity information and location of the product for accountability purposes. The firm requests that all customers contact their customer service representative at 1-800-950-2763 for a Return Goods Authorization (RGA) # and shipping account number. All shipping costs, including those from customers, will be paid for by CP Medical. Replacement product (at no cost) will be provided.

Device

Monoswift
  • Modelo / Serial
    Lot 130826-08, expiration 2015-07.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide
  • Descripción del producto
    Monoswift¿ PGCL [poly (glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0 PGCL; part number L936. Product is labeled sterile. The product is sealed inside an inner foil pouch with an outside Tyvek¿ pouch. It is an undyed, monofilament synthetic absorbable suture with needle, size 3/0 (2.0 metric), PS-1 Needle
  • 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