Rappel de EP Cables

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 Sterilmed 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
    49510
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0554-2009
  • Date de mise en oeuvre de l'événement
    2008-08-08
  • Date de publication de l'événement
    2009-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
  • Date de fin de l'événement
    2011-04-26
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
  • 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 cable - Product Code IKD
  • Cause
    Sterimed, inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. the removal is being conducted because the possibility exists that some of the pouches were not properly sealed on one end. a breach in packaging seal or a failure in packaging integrity has the possibility of risk to the patient in terms of transmitting organisms capable.
  • Action
    Consignees were notified of the recall via verbal communication in person by on-site technician and or their local sales representative on 8/8/08. Others were contacted via fax or e-mail followed by on-site visits 8/11/08. SteriMed also provided consignees (Materials Manager/Risk Manager) with a "Urgent Product Removal" recall letter (August 14, 2008) in person informing them of the potential of receiving affected product. Included in the Product Removal Notification was a Customer Reply Form to inventory quantity of product received and quantity returned. Contact SterilMed, Inc. at 1-888-541-0078 for assistance.

Device

  • Modèle / numéro de série
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, and WV OUS: CANADA
  • Description du dispositif
    EP Cables || Model #'s: || BAR560004P || BIOC10MR10MSTKS || BIOC5-MH/NAVMH-S || CORC6-MR10/EPTR-S || DAI401972 || DAI401976 || DAI401977 || DAI401981 || DAI401983 || EPT5454S || EPT613 and || EPT651 || An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine.
  • Manufacturer

Manufacturer

  • Adresse du fabricant
    Sterilmed Inc, 11400 73rd Ave N Ste 100, Osseo MN 55369-5562
  • Société-mère du fabricant (2017)
  • Source
    USFDA