Events

Retiro De Equipo (Recall) de Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV)

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 Synovis Surgical Inovation Div. of.

¿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
    37671
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0961-2007
  • Fecha de inicio del evento
    2007-03-16
  • Fecha de publicación del evento
    2007-06-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-02-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=51279
  • 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
    Surgical Mesh - Product Code FTM
  • Causa
    Package integrity/sterility compromised-the foil pouch in the peri-strips dry with veritas collagen matrix circular staple line reinforcement has a potential for minute defects which may compromise the sterility of the outside of the tray in which the device is packaged.
  • Acción
    Recall notification letters were sent to hospitals via Federal Express on 03/16/2007. This letter describes the product being recalled and problem. It requests consignees to complete and fax back the product return form. EXPANDED Another recall letter dated 04/23/2007 was sent to inform customers of 17 aditional lot numbers being recalled. A third recall letter dated 05/05/2007 was set to hospitals to inform them of one additional Lot/Serial number that was affected. This letter also requests a product return form be completed and faxed to Synovis Surgical Innovations.

Device

Device Recall PetriStrips Dry with Veritas Collagen Matrix (PSDV)
  • Modelo / Serial
    5719288-345247, 5720137-358402, 5720206-359198, 5721249-375999, 5721733-391018, 5723148-421902, 5722090-397033, 5722420-406658, 5723509-433792, 5723703-439270, 5723810-441317, 5724696-467329, 5725034-478977, 5725483-487063, 5725792-495462, 5726121-498548, 5726493-506246, 5721249-540340, 5726841-516569. EXPANDED LOT/SERIAL #'s: 5726841-560767, 5726842-516570, 5727664-532483, 5727970-538817, 5727971-538818, 5728410-544892, 5728683-549953, 5729326-562208, 5729700-569547, 5729701-569548.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide including states of AZ, CA, CT, FL, IA, IL, IN, KY, MA, MI, MN, MO, NJ, NY, OH, OK, PA, TN, TX, VA, and WI
  • Descripción del producto
    Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 25-E-V), 25mm, Ethicon Circular stapler. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip
  • Manufacturer
    Synovis Surgical Inovation Div. of

Manufacturer

Synovis Surgical Inovation Div. of
  • Dirección del fabricante
    Synovis Surgical Inovation Div. of, 2575 University Ave W, Saint Paul MN 55114-1073
  • Source
    USFDA