Events

Rappel de Device Recall AdTech Electrode Connection System/Cables

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Ad-Tech Medical Instrument Corporation.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    73685
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1503-2016
  • Date de mise en oeuvre de l'événement
    2016-03-29
  • Date de publication de l'événement
    2016-04-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-08-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144756
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Electrode, depth - Product Code IKD
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    Lot Numbers: 208140507, 208140552, 208140556, 208140559, 208140560, 208140561, 208140562, 208140563, 208140564R, 208140579, 208140581, 208140586, 208140588R, 208140590, 208140604.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in the states of GA and MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and BRAZIL.
  • Description du dispositif
    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