Events

Rappel de Device Recall Tegaderm

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 Medical Action Industries 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
    73237
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1036-2016
  • Date de mise en oeuvre de l'événement
    2016-02-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-06-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143609
  • 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
    Dressing, wound, drug - Product Code FRO
  • Cause
    Misbranding; due to the presence of chg in the tegaderm picc/cvc dressing change convenience kit, which is not identified on the exterior labeling.
  • Action
    Medical Action Industries, Inc. sent an Urgent Medical Device Recall letter dated February 3, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to immediately examine their inventory and quarantine all product subject to this recall. Consignees were also instructed if product was further distributed to identify their consignees and notify them at once of this product recall. Recalled product should be returned to Medical Action Industries for credit or replacement by contacting quality@owens-minor.com . Consignees were asked to complete and return the enclosed response form. Consignees with questions were instructed to call 828-338-7630.

Device

Device Recall Tegaderm
  • Modèle / numéro de série
    Kit #73775, Lot 213403
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to MO, NE and TX .
  • Description du dispositif
    PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. || This kit is used by clinicians to change dressings
  • Manufacturer
    Medical Action Industries Inc

Manufacturer

Medical Action Industries Inc
  • Adresse du fabricant
    Medical Action Industries Inc, 25 Heywood Rd, Arden NC 28704-9302
  • Société-mère du fabricant (2017)
    Owens & Minor Inc
  • Source
    USFDA