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
    69373
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0140-2015
  • Fecha de inicio del evento
    2014-09-22
  • Fecha de publicación del evento
    2014-10-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130358
  • 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 five lots of monoswift pgcl [poly(glycolide-co-caprolactone)] absorbable surgical suture for failing to meet the minimum tensile strength as dictated by usp was not met over the length of the product's shelf life.
  • Acción
    CP Medical Inc.notified their customers between September 23 through October 3, 2014, of the recall via telephone or e-mail and followed up with a certified letter. Customers were advised to discontinue sale and/or use of the recalled product and return all existing stock to CP Medical. CP Medical also requested their customers to notify their downstream customers of the recall and request they return any unused recalled product, as well as provide information to them regarding distribution of the product. Customers are being asked to fill out and return a questionnaire regarding the recalled product and contact CP Medical Customer Service Representative at 1-800-950-2763 for return authorization and shipping account number. All shipping costs including those from downstream customers will be paid for by CP Medical. Replacement product or credit will be provided.

Device

Monoswift
  • Modelo / Serial
    Product Lot Number (s) Code  L345; 130618-12. L346; 140304-14. L463; 130513-16. L923; 130729-17; 140127-02. L942; 140117-03; 140128-06.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution including the states of: AR, AZ, CA, FL, ME, MI, NE, OR, SC, and WA
  • Descripción del producto
    Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. 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.
  • Manufacturer
    C P Medical, Inc.

Manufacturer

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