Events

Rappel de Device Recall Medtronic Custom Kits

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 Cardiovascular Revascularization & Surgical Therap.

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
    51785
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1551-2009
  • Date de mise en oeuvre de l'événement
    2009-03-23
  • Date de publication de l'événement
    2009-07-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81270
  • 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
    Separator, automated, blood cell, diagnostic - Product Code OEU
  • Cause
    Medtronic has identified a small number of one source kits and maxpac/total system lots with incorrect use before dates on the outer kit package label. the use before date on the outer label of the kit/pack does not accurately reflect the use before date of the components within the kit/pack. for affected product, the outer label lists a date which exceeds the earliest use before date of the com.
  • Action
    An "Urgent Medical Device Recall Notice" dated March 23, 2009 was sent to customers describing the affected device. Consignees were asked to quarantine product, complete and sign a certificate indicating acknowledgement of the notification and the amount of affected product at the facility, and to return the affected product. For further questions, contact Medtronic at 1-763-514-9605.

Device

Device Recall Medtronic Custom Kits
  • Modèle / numéro de série
    Lot Numbers: 0000567714, 0000569193, 0000569453, 0000571627, 0000574238, 0000579154, 0000579157 and 0000580322.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- US including states of AZ, CA, CO, CT, DE, FL, HI, IL, IN, LA, MI, MN, NC, NJ, NM, NV, NY,OH, OK, PA, TN, TX, and WI and countries of Australia, Japan and Venezuela.
  • Description du dispositif
    Medtronic One Source Pack Magellan, Catalog Number: COS310. || Kits are packaging convenience kits containing previously released sterile-pack products and accessories. || Medtronic Ideal MAXPAC Total System
  • Manufacturer
    Medtronic Cardiovascular Revascularization & Surgical Therap

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • Adresse du fabricant
    Medtronic Cardiovascular Revascularization & Surgical Therap, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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