Events

Rappel de Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain

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 Medela 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
    59453
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3172-2011
  • Date de mise en oeuvre de l'événement
    2011-07-27
  • Date de publication de l'événement
    2011-09-08
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102825
  • 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
    Wound Dressing Kit - Product Code MCY
  • Cause
    Medela determined that some of the individual kits or bags of lot #370118 of "0877061 wound dressing set, tier i, 10 mm flat drain", were labeled incorrectly as "0877067 wound dressing set, tier iii 15 fr round channel drain". the outside label on the case is correctly labeled as "0877061 wound dressing set, tier 1,10 mm flat drain".
  • Action
    Medela Inc. sent an "Urgent Device Recall" letter dated July 26, 2011 to all affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: 1) not to use the affected lot and place them in quarantine 2) stop sale and distribution and set aside their existing inventory of the affected product 3) conduct a physical count and record the data on the Product Inventory Form included with this letter 4) complete and return the Product Inventory Form via fax to 800-995-7867 or e-mail suction@medela.com, even if they have no affected product on hand 5)if they have the affected product in stock, Medela Customer Service will ship substitute product to the customer at no cost. 6) and to record the number of units on hand for return and replacement on the enclosed Product Inventory Form. The completed form should be returned via fax or e-mail to Medela even if the account has no inventory of the affected lots. If you have any questions about this recall please call (877) 735-1626 or e-mail at suction@medela.com.

Device

Device Recall Invia Wound Therapy Tier I Wound Dressing Kit, 10 MM Flat Drain
  • Modèle / numéro de série
    product code 0877061, lot 370118, some of which were mislabeled as product 0877067, lot 370118
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including the states of California, Florida, Georgia, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Mississippi, New Jersey, New Mexico, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee and Texas.
  • Description du dispositif
    Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061. || Medela Healthcare, || McHenry, IL 60051; || A Wound Drain Kit containing a 10 mm Flat Drain, antimicrobial gauze pad, non-adherent wound contact layer, transparent dressing, tubing clamp, barrier film wipe, adhesive tape, sterile saline, and suction extension tubing; 15 individually bagged kits per case; || Some of the kits were mislabeled as Invia Wound Therapy Tier III Wound Dressing Kit, 15 Fr Round Channel Drain, product 0877067, lot 370118
  • Manufacturer
    Medela Inc

Manufacturer

Medela Inc
  • Adresse du fabricant
    Medela Inc, 1101 Corporate Dr, Mchenry IL 60050-7006
  • Société-mère du fabricant (2017)
    Olle Larsson Holding Ag
  • Source
    USFDA