Retiro De Equipo (Recall) de Device Recall Percuvance Johans Grasper Tool Tip

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 Teleflex 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Causa
    For some of the recalled products, the security of the connection between the shaft and the tool tip may be compromised. for certain other recalled lots of the products, the jaws of the tool tips may close abruptly.
  • Acción
    Teleflex sent an Urgent Medical Device Recall Notification letter dated July 19 , 2017, to all affected consignees communicating the following on their recall of Percuvance Percutaneous Surgical System: Consignees were advised to take the following actions. 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to This will allow us to document your receipt of this letter. Customers with any other questions, should contact their local sales representative or Customer Service at 1-866-246-6990.


  • Modelo / Serial
    Lot #'s: 73A1600104, 73B1600339, 73C1600291, 73C1600454, 73D1600586, 73E1600586, 73G1600016, 73G1600558, 73G1600728, 73H1600148, 73H1600507, 73H1600901, 73J1600061, 73J1600601, 73L1600024, 73L1600376, 73L1600559, 73M1500035, and 73M1500300
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US including AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV Internationally to United Arab Emirates, Vienna, Australia, Belgium, Switzerland, China, Germany, Czech Republic, Spain, Finland, France, United Kingdom, Hong Kong, Ireland, Israel, Iran, Italy, Japan, South Korea, R¿publique du Liban, Netherlands, Norway, Qatar, Romania, Saudi Arabia, Republic of Singapore, Turkey, Taiwan, and South Africa
  • Descripción del producto
    Percuvance Johans Grasper Tool Tip || The Percutaneous Surgical System with 5mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the abdomen. The system is used to grasp, manipulate, cut, cauterize and deliver Hem-o-lok ligating clips to soft tissue during laparoscopic surgery.
  • Manufacturer


  • Dirección del fabricante
    Teleflex Medical, 3015 Carrington Mill Blvd, Morrisville NC 27560-5437
  • Empresa matriz del fabricante (2017)
  • Source