Events

Retiro De Equipo (Recall) de Device Recall Stryker Woundcare Tubing Replacement Sets

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 Stryker Instruments Div. of Stryker Corporation.

¿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
    71271
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2062-2015
  • Fecha de inicio del evento
    2015-05-08
  • Fecha de publicación del evento
    2015-07-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137181
  • 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
    Lavage, jet - Product Code FQH
  • Causa
    Potential sterility breach in the packaging.
  • Acción
    Stryker sent Customer Notification Letters on 05/20/2015 through Certified mail via USPS. Customers are asked to do the following: Immediately review this Recall Notification. Immediately check all stock areas and/or operating room storage and quarantine any affected product found. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you do not have any affected product on hand. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. Fax (866-521-2762) or email (julie.forsyth@stryker.com) the completed Business Reply Form to Stryker Instruments Regulatory Department. Upon receipt of the Business Reply Form, if you have recalled product on hand, Stryker will email a pre-paid shipper. This shipper can be used to return the recalled WoundCare Replacement kits to Stryker.

Device

Device Recall Stryker Woundcare Tubing Replacement Sets
  • Modelo / Serial
    0210-312-000: 12138012, 12203012, 12229012, 12256012, 12293012, 12314012, 12338012, 13086012, 13140012, 13192012; 0210-318-000: 14140012,14258012; 0210-318-100: 12294012,13051012; 0210-318-200: 12143012, 12293012, 13066012, 14037012, 14112012
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution-including the states of FL, IA, IL, IN, LA, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WI.
  • Descripción del producto
    0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Dirección del fabricante
    Stryker Instruments Div. of Stryker Corporation, 4100 E Milham Ave, Portage MI 49002-9704
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA