Events

Retiro De Equipo (Recall) de Device Recall AdTech Electrode Connection System/Cables

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 Ad-Tech Medical Instrument 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
    73685
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1503-2016
  • Fecha de inicio del evento
    2016-03-29
  • Fecha de publicación del evento
    2016-04-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-08-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144756
  • 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
    Electrode, depth - Product Code IKD
  • Causa
    Ad-tech is recalling unopened/unused sterile cables intended to be used only with all compatible ad-tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators. this recall has been initiated due to package failures (i.E. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
  • Acción
    Consignees were sent a "Medical Device Recall" letter dated March 29, 2016. The letter described the problem and the product being recalled. Advised consignees to immediately examine their inventory, quarantine and return the product to AD-Tech. If the product has been further distributed identify customers and notify them of the recall. Requested consignees to complete and return the "Medical Device Recall Return Response" form to their Ad-Tech Clinical Specialist at customersupport@adtechmedical.com; FAX: 262-634-5668 or Telephone 262-634-1555. For questions contact Ad-Tech Clinical Specialist. .

Device

Device Recall AdTech Electrode Connection System/Cables
  • Modelo / Serial
    Lot Numbers: 208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604.
  • Clasificación del producto
    Physical Medicine Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed in the states of GA and MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and BRAZIL.
  • Descripción del producto
    Ad-Tech Electrode Connection System/Cables. Lightweight TECH-ATTACH Cable Models: || 1. L-DCL-4DINX (4 contacts: 1 terminal block with 4 connectors each); || 2. L-DCL-6DINX (6 contacts: 1 terminal block with 6 connectors each); || 3. L-DCL-8DINX (8 contacts: 1 terminal block with 8 connectors each); || 4. L-DCL-16BDINX (16 contacts: 1 terminal block with 16 connectors each); || 5. L-DCL-32BDINX (32 contacts: 2 terminal blocks with 16 connectors each); || 6. L-DCL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). || FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts: 1 terminal block with 4 connectors each). || Tech-Attach: these cables require the use of an additional component - the connector block. The tail of the electrode is inserted into the block and the block in turn mates with the cable. A key-pin is used to ensure proper orientation. The cable terminated in EEG compatible connector sockets. || Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts: 4 terminal blocks with 16 connectors each). Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached. The tail of an electrode is inserted into this portion which then hinges shut.
  • Manufacturer
    Ad-Tech Medical Instrument Corporation

Manufacturer

Ad-Tech Medical Instrument Corporation