Events

Rappel de MIDAS TOUCH NEEDLE ELECTRODE

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 Kentucky Packaging Service LP.

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
    53482
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0140-2010
  • Date de publication de l'événement
    2009-11-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-10-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85595
  • 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
    There were inconsistencies noticed on the insulation overlap. the electrode has a large diameter shaft that transitions to a smaller diameter shaft. the 1st layer of insulation which covers the small diameter shaft overlaps with the 2nd layer of insulation that covers the larger diameter shaft. on some electrodes it appears that the overlap is too short to cover the transition which makes this.
  • Action
    Olsen Medical issued an "Urgent: Device Recall" letter to Consignees beginning September 24, 2009 . Customers were instructed to inventory their stock and for all remaining product immediately discontinue use and return. Consignees were also instructed to contact their customers and notify them of the recall. For further information, contact Olsen Medical at 1-502-772-4272.

Device

MIDAS TOUCH NEEDLE ELECTRODE
  • Modèle / numéro de série
    Model Number: 30-1011, Lot Numbers: 011898, 012733, 012988 and 013373; Model Number: 30-1012, Lot Number: 012244; Model Number: 30-1013, all lots; Model Number: 30-1014, Lot Numbers: 011668, 011970 and 012997; and Model Number: 30-6011, Lot Numbers: 012565, 012800 and 012983.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution -- AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA.
  • Description du dispositif
    Olsen Medical, MIDAS TOUCH ¿ NEEDLE ELECTRODE, WITH MODIFIED TIP. Model Numbers: 30-1011, 30-1012, 30-1013, 30-1014 and 30-6011.
  • Manufacturer
    Kentucky Packaging Service LP

Manufacturer

Kentucky Packaging Service LP
  • Adresse du fabricant
    Kentucky Packaging Service LP, 3001 W Kentucky St, Louisville KY 40211-1505
  • Source
    USFDA