Events

Rappel de Device Recall ONE SOURCE PACK, Model TK2S24

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 Medtronic 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
    54237
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-0869-2010
  • Date de mise en oeuvre de l'événement
    2009-12-14
  • Date de publication de l'événement
    2010-02-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-04-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88089
  • 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
    Cardiopulmonary bypass accessory equipment. - Product Code KRI
  • Cause
    Medtronic has identified a small number of autotransfusion one source kits and maxpac/total system lots with incorrect use before dates (ubd) on the outer kit package label. the ubd on the outer label of the kit/pack does not accurately reflect the ubd of the components within the kit/pack. for affected product, the outer label lists a date which may be later than the usb of the components inclu.
  • Action
    Consignees were sent a Medtronic "Urgent Medical Device Recall Notice" dated December 14, 2009. The letter was addressed to "Valued Customer." The letter described the product and the problem and requested them to quarantine the product and to complete and sign the attached certificate, "Medtronic Recall Certificate (FCA 1002)." For additional information, contact the firm at 763-514-9605.

Device

Device Recall ONE SOURCE PACK, Model TK2S24
  • Modèle / numéro de série
    Lot #: 1093645, 1102929, 1139554
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    CA, CO, JAPAN, CHINA.
  • Description du dispositif
    ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604.
  • Manufacturer
    Medtronic Inc

Manufacturer

Medtronic Inc
  • Adresse du fabricant
    Medtronic Inc, 710 Medtronic Pkwy, Minneapolis MN 55432-5603
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA