Events

Retiro De Equipo (Recall) de Device Recall SS wire suture

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 Creek Dr.

¿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
    38220
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1015-2007
  • Fecha de inicio del evento
    2007-06-06
  • Fecha de publicación del evento
    2007-07-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2008-03-14
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53178
  • 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
    Suture - Product Code GAM
  • Causa
    Suture diameter/strength specification failure: the products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
  • Acción
    Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.

Device

Device Recall SS wire suture
  • Modelo / Serial
    SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, Lot #105821; SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8, Lot #80513;  SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, Lot #1015798;  SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, Lot #67227;  SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6 SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4, Lot #67228;  SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, Lot #39238;  SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, Lot #8727; SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399. Lot #72507.
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
  • Descripción del producto
    Various Types, Sterile/Nonsterile Stainless Steel Nonabsorable Surgical Sutures-SS Wire, STL MF 7 HSCX48 1N 18 X2, Catalog #29-6567M2; SS Wire, STL MF 6 HSCX48 1N 18 X6, Catalog #29-6619M6, SS Wire, STL MF 6 K-60 1N 18"X8, Catalog #29-7270M8,SS Wire, STL MF 5 K-60/ B-60 1N18 X7, Catalog #29-9001M7, SS Wire, STL MF 5 K-61 1N 2X30, Catalog # E2-5367M2, SS Wire, STL MF 5 K-60 1N 6X18, Catalog # E29-5652M6, SS Wire, STL MF 6 K-60 1N 4X18, Catalog # E29-7270M4,SS Wire, STL MF 5 K-60 1N 45CM, Catalog # E29-7272B, SS Wire, STL MF 5 K-60 2N 30, Catalog #X-2235, SS Wire, STL MF 0 KC-6 1N 18, Catalog #X-3399.
  • Manufacturer
    Teleflex Creek Dr

Manufacturer

Teleflex Creek Dr
  • Dirección del fabricante
    Teleflex Creek Dr, 4024 Stirrup Creek Dr, Durham NC 27703-9000
  • Source
    USFDA