Events

Rappel de Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir

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 LivaNova USA.

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
    79863
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1918-2018
  • Date de mise en oeuvre de l'événement
    2018-03-13
  • 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=163774
  • 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
    Oxygenator, cardiopulmonary bypass - Product Code DTZ
  • Cause
    Some integrated sterile inspire family products contain an incorrect expiration date printed in the unique device identification (udi) bar code and readable code just beneath the barcode. specifically, the expiration date is reported as ddmmyy instead of yymmdd. the expiration date in the applicable field on the package labels are correct as printed.
  • Action
    On March 13, 2018, notification letters were emailed. Customers were instructed to return response forms, which indicated the following: amount of unused product, and whether they would contact the firm to relabel effected products or if they preferred to be trained on the relabeling procedure. If product was further distributed, customers were instructed to send the notification letter to these additional customers within 2 business days. No action is required for product already used since it was consumed prior to the true expiration date. For further questions, please call (281) 228-7260.

Device

Device Recall INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy rese...
  • Modèle / numéro de série
    Lot: 1709190228, UDI: (01)08033178112352(17)200917(10)1709190228, Exp: 09/17/2020
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : NJ, CA, MN, MO, MA
  • Description du dispositif
    Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 || The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: The INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less
  • Manufacturer
    LivaNova USA

Manufacturer

LivaNova USA
  • Adresse du fabricant
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA