Events

Rappel de Device Recall ThermoGard Dual Dispersive Electrodes

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 Conmed 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
    73607
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2597-2016
  • Date de mise en oeuvre de l'événement
    2016-05-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-05-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=146781
  • 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
    Electrosurgical, cutting &; coagulation &; accessories - Product Code GEI
  • Cause
    A version of the dual dispersive electrodes may not be compatible with some electrosurgical generators, placing patients at risk for undetected pad lift and a potential burn.
  • Action
    On May 17, 2016 CONMED Corporation distributed Urgent Device Recall notification letters and Business Reply Forms to their customers via courier service. CONMED Corporation has decided to recall these ThermoGard¿ Dual Dispersive Electrodes for all customers who do not use an electrosurgical generator that employs the Contact Quality Monitoring systems listed. If your electrosurgical generator is not listed, your generator should not be used with the lot codes of the ThermoGard Dual Dispersive Electrodes identified. Customers are advised to inspect inventory for any of the recalled devices. If you use the ThermoGard¿ Dual Dispersive Electrodes in conjunction with an electrosurgical generator listed, no further action is required. However, if your electrosurgical generator and CQM system is not listed above, do not use the affected lot codes of ThermoGard¿ Dual Dispersive Electrodes. Please note that ThermoGard¿ Dual Dispersive Electrodes produced after July 5, 2015, are not subject to this recall. Customers should contact all of those departments or organizations within their facility and any other facilities that you may have supplied or given these affected products to. It is imperative that all end users of these devices receive this notice and respond immediately. If you have questions, please contact Patricia Cotter, CONMED Recall Coordinator 315-624-3237 (8AM-5PM EST, M-F) or fax to 315-624-3225 or email thermog@CONMED.com.

Device

Device Recall ThermoGard Dual Dispersive Electrodes
  • Modèle / numéro de série
    Beginning Lot Code 141001X with Ending Lot Code 20150705X.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA, including AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, & Puerto Rico; and, the countries of Australia, Canada, Belgium, Brunei Darussalam, China, France, Guatemala, Hong Kong, Israel, Italy, Japan, South Korea, Malaysia, Mexico, New Zealand, Norway, Portugal, Saudi Arabia, Spain, Sweden, and United Arab Emirates.
  • Description du dispositif
    Pediatric Dual Dispersive Electrodes (for patients 5-15 kg.), use with the Birtcher Pad Sensing System (PSS) on the Birtcher Systems 6000, 6400, 6500 and CONMED Systems 7500 and 7550 ABC¿ generators or conventional electrosurgery units with similar contact monitoring systems, 10' (3.05m) Cable, Catalog Number 7-383. || Intended to be used for the dispersion and return to the electrosurgical generator.
  • Manufacturer
    Conmed Corporation

Manufacturer

Conmed Corporation
  • Adresse du fabricant
    Conmed Corporation, 310 Broad St, Utica NY 13501-1203
  • Société-mère du fabricant (2017)
    CONMED Corp.
  • Source
    USFDA