Events

Rappel de Corometrics Qwik Connect Plus Spiral 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 Vital Signs Devices, a GE Healthcare Company.

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
    63481
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0330-2013
  • Date de mise en oeuvre de l'événement
    2012-10-16
  • Date de publication de l'événement
    2012-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113969
  • 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, circular (spiral), scalp and applicator - Product Code HGP
  • Cause
    Thirty fetal scalp electrodes were found to have an incomplete package seal and lacked the printed lot number stamped on during sealing.
  • Action
    The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter on October 16, 2012 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: DO NOT use Qwik Connect Plus Spiral Electrodes part number 7000AAO with lot number S03123 or product with missing lot numbers; isolate all affected product; complete and return the Urgent Medical Device Correction Confirmation form via fax at 800-535-7923, return form even if no recall product is in inventory; to return only unused product, and if they have forwarded any affected lot numbers of this product to any other healthcare institutions, forward a copy of this letter to those institutions. If you have any questions or concerns regarding this notification, contact GEMSIT Customer Service at +1-800-588-7044 (Domestic) or Vital Signs Customer Service at +1-800-932-0760 (International). Hours of operation: 8:00 am EST to 6:00 pm EST.

Device

Corometrics Qwik Connect Plus Spiral Electrode
  • Modèle / numéro de série
    Lot #S03123 Model #7000AA0
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states: AZ, CA, CT, FL, GA, IL, KS, KY, MA, MD, MN, MO, NJ, NM, NY, OH, PA, SC,TX, WA, and WY; and countries of: Australia and Canada.
  • Description du dispositif
    Corometrics Qwik Connect Plus Spiral Electrode- Model #7000AA0 || A fetal scalp circular (spiral) electrode and applicator is a device used to obtain a fetal electrocardiogram during labor and delivery.
  • Manufacturer
    Vital Signs Devices, a GE Healthcare Company

Manufacturer

Vital Signs Devices, a GE Healthcare Company
  • Adresse du fabricant
    Vital Signs Devices, a GE Healthcare Company, 20 Campus Rd, Totowa NJ 07512-1210
  • Société-mère du fabricant (2017)
    General Electric Company
  • Source
    USFDA