Events

Retiro De Equipo (Recall) de Boston Scientific Peristaltic Tubing Kit, Model 2104

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 Boston Scientific 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
    56909
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0170-2011
  • Fecha de publicación del evento
    2010-11-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-04-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94904
  • 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
    Cardiac ablation percutaneous catheter - Product Code LPB
  • Causa
    Boston scientific is conducting a recall on circucool¿ tubing sets used with the chilli ii¿ cooled ablation system because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. even though there have been no reported complaints.
  • Acción
    Boston Scientific Corporation sent an Urgent Medical Device Recall letter, dated September 27, 2010, to all customers via overnight Federal Express. The letter described the product, the problem, and the action the customer should take. The letter instructed customers to cease distribution of affected devices and remove them from their inventory, segregate in a secure location for return to Boston Scientific. A Reply Verification Tracking Form was to be completed and returned via email or faxed to (510) 624-2475 even if the customer did not have any of the affected product. If affected units were located the customer was to call (510) 624-2563 to obtain a Returned Good Authorization (RGA) Number and return to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: _________________ For additional questions call (510) 624-2563.

Device

Boston Scientific Peristaltic Tubing Kit, Model 2104
  • Modelo / Serial
    Lot: 61035169, 61071543, 61066975, 61066976, 61088879, 61088880, 61088881, 61088882, 61090636
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV and the countries of France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, Saudi Arabia, Spain, and Taiwan
  • Descripción del producto
    Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide. Contents: peristaltic pump fluid delivery extension tube set. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA. || Tubing Set (model 2104) for use with Boston Scientific Cooled Ablation System.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA