Events

Retiro De Equipo (Recall) de Polybond

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
    37756
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0807-2007
  • Fecha de inicio del evento
    2007-04-03
  • Fecha de publicación del evento
    2007-05-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-08-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51466
  • 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 - Product Code GAT
  • Causa
    Potential for sterility of product to be compromised. suture package seals incomplete or missing.
  • Acción
    On 04/03/2007 the firm notified its Polyester product (Polybond) customer by telephone and followed up on 04/09/2007 with a letter via certified mail requesting the distributor to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/09/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical. On 04/20/2007 the firm notified its Polypropylene and Polydioxanone product customers by letter dated 04/17/2007 via certified mail requesting distributors to discontinue sales of the affected product lot, to notify their customers of the issue, and return stock to CP Medical. The firm provided the distributor with a letter dated 04/18/2007 to be provided to the distributor's customers requested those customers to discontinue use of the affected product lots and return stock to their distributor who in turn are to return product to CP Medical.

Device

Polybond
  • Modelo / Serial
    Product label is coded CP523A. Lot numbers include: I0625120 expiration 2011-08, and I0627120-01 expiration 2011-08.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Firm distributes products to human and veterinary medical device distribution centers worldwide. Polybond Polyester sutures, product CP523A, were distributed to one distribution center in South Africa. Polypropelene sutures, product 8665, were distributed to veterinary distribution centers in OH, OR, and NE for nationwide distribution. Polydioxanone sutures, product M398A, were distributed to human and veterinary distribution centers in AZ, IA, OH, LA, MA, MI, MO, NE, and TX for nationwide distribution.
  • Descripción del producto
    Product is an EO Sterile, Polyester braided and coated nonabsorbable surgical suture with double needle, size 2/0 (3.0 Metric), NSH 26 mm TAPER Needle. Product is wrapped in a five-fold card with inserted flap ends (overwrap). A label is placed on the overwrap and the packet is then inserted into a tyvek/mylar pouch. One end of the overwrap card is printed with 'Open'. This end is positioned in the pouch so it is closest to the peel-open end. No suture is exposed or visible through the overwrap which must be torn to have access to the suture and needle. Product is boxed (12 to a box) and shrink wrapped. || Product overwrap label includes: '2/0 (3.0 metric) CP523A Polybond Green Braided, Polyester Coated Nonabsorbable Sterile Suture Rx Only TAPER NSH 36' (90cm) 1/2 26mm Manufactured by CP Medical Portland, OR USA'. || Product box label includes: '2/0 (3.0 metric) CP523A NSH 26 mm 1/2 TAPER POLYBOND Green Polyester Braided Coated Nonabsorbable 36' (90cm) STERILE EO Manufacturer CP Medical Portland, OR USA' . || Product was distributed to single consignee, a distributor in South Africa.
  • Manufacturer
    C P Medical

Manufacturer

C P Medical
  • Dirección del fabricante
    C P Medical, 803 Ne 25th Ave, Portland OR 97232
  • Source
    USFDA