Events

Rappel de Device Recall AVID Medical QA Pack

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 Avid Medical, 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
    79135
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0581-2018
  • Date de mise en oeuvre de l'événement
    2017-07-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-04-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161426
  • 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
    General surgery tray - Product Code LRO
  • Cause
    The swab stick collection device provided in a convenience kit expires prior to the kit expiration date.
  • Action
    Avid Medical began shipping this product on 05/23/2017. Immediately examine your inventory and quarantine all product subject to this correction. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product correction. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Correction notice. Please complete the attached Correction Response Form as soon as possible. Attached is a label template for use in the generation of an appropriate warning label for application on all AV10654-10 inventory of impacted lot 1235229. This label should be applied to each affected convenience kit and product case in a prominently visible location to end-users. The location chosen should not cover any other critical product information found on existing product labeling. If you prefer to have labels printed for your facility, please send quantity and end-user location information request to sharon.moll@owens-minor.com. Replacement component swab stick collection systems are available upon request. This correction will be executed with oversight of the associated account sales rep. Please complete and return the enclosed response form as soon as possible.

Device

Device Recall AVID Medical QA Pack
  • Modèle / numéro de série
    Avid Medical Kit Lot 1235229 (expiration date 2017-08-01); Swab Stick lots: 5M03A (expiration date 2017-06-03) and 6A21A (expiration date 2017-07-21)
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Seventeen sites located in 13 states: FL, IN, KS, KY, MA, OK, NC, NE, NY, OH, PA, VA, and TX.
  • Description du dispositif
    AVID Medical QA Pack AV10654-10
  • Manufacturer
    Avid Medical, Inc.

Manufacturer

Avid Medical, Inc.
  • Adresse du fabricant
    Avid Medical, Inc., 9000 Westmont Dr, Toano VA 23168-9351
  • Source
    USFDA