Events

Rappel de Device Recall Medstorm Adult Radiolucent 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 Heart Sync, Inc.

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
    57736
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1371-2011
  • Date de mise en oeuvre de l'événement
    2010-12-17
  • Date de publication de l'événement
    2011-02-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-07-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97446
  • 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, electrocardiograph, multi-function - Product Code MLN
  • Cause
    The seal on the electrode pouch may be open, exposing the electrode to the outside environment. the package does have a caution statement that states, " do not open package until immediately prior to using electrodes. and electrodes may dry out when removed from packaging and exposed to air.
  • Action
    Heart Sync, Inc sent an URGENT MEDICAL DEVICE RECALL letter dated December 23, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Examine their inventory and quarantine product that was subject to the recall that was not sealed properly. Contact any customers if they further distributed the product and notify them at once of this product recall. Contact the firm if they had any unused product. The firm would issue a UPS Call Tag to have the product returned to them and the firm would send replacement product as soon as they were notified. Complete and return the Recall Return Response Form to the firm in the attached prepaid envelope. For any questions regarding this recall call 734-213-5530.

Device

Device Recall Medstorm Adult Radiolucent Electrode
  • Modèle / numéro de série
    Lot Y-032709
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including AK, AZ, CA, FL, IL, KS, LA, MA, ND, NM, OH, TX, WA, WI and WV; and Canada
  • Description du dispositif
    Medstorm Adult Radiolucent Electrode  Philips Medical , Part #16250, HeartSync Ann Arbor, MI. || The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use only. The electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous cardiac pacemaker and the patients skin. When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the respective low power mono-phasic or bi-phasic defibrillator (360 joules maximum) or external pacemaker.
  • Manufacturer
    Heart Sync, Inc

Manufacturer

Heart Sync, Inc
  • Adresse du fabricant
    Heart Sync, Inc, 5643 Plymouth Rd, Ann Arbor MI 48105-9586
  • Société-mère du fabricant (2017)
    Heart Sync, Inc
  • Source
    USFDA