Events

Retiro De Equipo (Recall) de WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hemolok(R) Clip Applier

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
    Recall
  • ID del evento
    78242
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0083-2018
  • Fecha de inicio del evento
    2017-10-05
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158986
  • 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
    Clip, implantable - Product Code FZP
  • Causa
    The product has a non-conformity that may cause clips to mislead, jam or fall out of the applier.
  • Acción
    The firm initiated their recall on 05 OCT 2017 via FedEx 2-day. The letter requested the following actions to be taken by hospitals to remove product from the facilities: "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 recalls@teleflex.com. 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 recalls@teleflex.com. This will allow us to document your receipt of this letter." Distributors were instructed as follows: "1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Using the provided customer letter and recall acknowledgement form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. In the event that an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990. 4. To return recalled products to Teleflex Medical, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. 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 (

Device

WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hemolok(R) Clip Applier
  • Modelo / Serial
    Lot numbers: 73A1700701, 73H1600582, 73B1700183, 73H1600583, 73B1700567, 73H1600663, 73C1600069, 73H1600664, 73C1600070, 73H1600665, 73C1600071, 73H1600666, 73C1700288, 73H1600667, 73C1700289, 73H1600668, 73C1700290, 73J1600135, 73C1700292, 73J1600136, 73C1700300, 73J1600137, 73F1600036, 73J1600138, 73F1600037, 73J1600139, 73F1600038, 73J1600414, 73F1600039, 73J1600415, 73F1600040, 73J1600416, 73F1600689, 73K1600118, 73F1600690, 73K1600457, 73F1600691, 73K1600458, 73F1600692, 73K1600497, 73F1600693, 73K1600514, 73F1600694, 73K1600614, 73G1600151, 73L1600528, 73G1600431, 73L1600529, 73G1600432, 73L1600530, 73G1600716, 73L1600531, 73G1600717, 73L1600532, 73H1500014, 73L1600563, 73H1500015, 73M1600200, 73H1500016, 73M1600201, 73H1600173, 73M1600202, 73H1600174, 73M1600279
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide and Australia, Canada, Singapore, Thailand, China, Taiwan, Belgium, Japan, S. Korea
  • Descripción del producto
    WECK(R) from TELEFLEX Auto Endo5(R), Automatic Hem-o-lok(R) Clip Applier, REF AE05ML (IPN010797) Rx ONLY, STERILE EO
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • Dirección del fabricante
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • Empresa matriz del fabricante (2017)
    Teleflex Incorporated
  • Source
    USFDA