Events

Rappel de Device Recall Neutralect

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 ConvaTec.

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
    54363
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1142-2010
  • Date de mise en oeuvre de l'événement
    2010-01-22
  • Date de publication de l'événement
    2010-03-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-06-10
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88334
  • 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
    diathermy cables - Product Code GEI
  • Cause
    Mislabeling: boxes labeled with the order code 3508m may contain a cable for the order code 3405m, and boxes labeled with order code 3405m may contain a cable for order code 3508m.
  • Action
    Unomedical Urgent Medical Device Correction letters were sent to distributors on January 22, 2010 by certified mail. Letters state that the only way to determine if the incorrect product is contained in the carton is to open the box. Distributors are asked to inspect all Diathermy Cables in their possession with order code 3508M or 3405M to ensure that the correct cable is inside. The number of mislabeled product is to be recorded on the Questionnaire for Distributors, and then mislabeled product is to be destroyed by cutting the product in half. The questionnaires include an area for names of customers stating that the distributor will contact them, or requesting that Unomedical contact them directly. Copies of the correction notice and questionnaire for end users are to be forwarded to all customers, asking them to complete the questionnaire and return it to the distributors. Once received by the distributors, end users can discard the cables by cutting them in half. All completed forms should be returned to Unomedical and local reps are to be contacted to arrange for replacement of mislabeled stock and/or credits.

Device

Device Recall Neutralect
  • Modèle / numéro de série
    Ref code 3508M, Ref Code 3405M, no expiration dates. Lot numbers: 568229, 568588, 568784, 569128, 620731, 621058, 621143, 621453, 621608, 622599, 622890.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution.
  • Description du dispositif
    Neutralect Diathermy Cable, || Unomedical Ltd., Ref code 3508M, and Ref Code 3405M.
  • Manufacturer
    ConvaTec

Manufacturer

ConvaTec
  • Adresse du fabricant
    ConvaTec, 200 Headquarters Park Dr, Skillman NJ 08558
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA