Events

Rappel de LIFEPAK(R) defibrillation 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 Physio-Control, 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
    78303
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0186-2018
  • Date de mise en oeuvre de l'événement
    2017-10-27
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159096
  • 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
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Cause
    The infant artwork on the product instructs incorrect pad placement. also, the artwork is missing the type bf patient connection and high voltage warning symbols.
  • Action
    The firm Physio Control, initiated their field action on 10/27/2017 by issuing a press release. The firm followed this with a recall notice dated 10/23/2017, to the direct consignees on 11/03/2017. The letter described the product, explained the problem and provided the following instructions: Quarantine the affected lots;contact Physio-Control at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday to arrange for replacement of your unused electrodes and "Upon receipt of this notification, post a copy of the enclosed Correct Electrode and Packaging Labeling with each of your AEDs, which shows the correct placement of the electrodes." Physio_Control will provide replacement products for all unused affected Electrodes. Should you have any questions about this Product Recall, please contact us at 1-866-231-1220, 6:00 A.M. to 4:00 P.M. (Pacific), Monday  Friday.

Device

LIFEPAK(R) defibrillation electrodes
  • Modèle / numéro de série
    713609, 717912, 713904, 718033, 715008, 719323
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (nationwide) including Puerto Rico and Guam and countries of: Canada, Austria, Belgium, Czech Republic; Denmark, Finland, France, French Polynesia, Germany, Hungary, Ireland, Italy, Latvia, Netherlands, Australia, China, Hong Kong, Japan, Argentina, Mexico, Norway, Panama, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom, and New Zealand.
  • Description du dispositif
    LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016, MIN #3202380-006 || The defibrillation electrodes are used only with LIFEPAK EXPRESS(R) AED, LIFEPAK CR(R) Plus AED, LIFEPAK 1000 defibrillator, or LIFEPAK 500 Biphasic AED s with a pink connector.
  • Manufacturer
    Physio-Control, Inc.

Manufacturer

Physio-Control, Inc.
  • Adresse du fabricant
    Physio-Control, Inc., 11811 Willows Rd NE, Redmond WA 98052-2003
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    USFDA