Events

Rappel de Device Recall Oxygen Masks, Elongated

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, 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
    77282
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2228-2017
  • Date de mise en oeuvre de l'événement
    2017-05-10
  • Date de publication de l'événement
    2017-05-24
  • 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=155601
  • 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
    Mask, oxygen - Product Code BYG
  • Cause
    Reports of tubing detaching from oxygen masks either prior to use (in packaging) or during use were made by different end users and for different batches. the failures were caused by an improper solvent bond between the oxygen tubing and the oxygen mask connector. while the defect affects less than 2% of recalled product, there is a potential for harm when oxygen supply to the user is disrupted.
  • Action
    Recall Letters were sent to consignees on May 10, 2017. The letter requested that they immediately stop distribution and quarantine all affected lots. The letter also requested a sub-recall if the product had been further distributed. Also attached to the letter is a Recall Response Form to be returned.

Device

Device Recall Oxygen Masks, Elongated
  • Modèle / numéro de série
    Lot Number 102153, 102339, 102941, 103176, 103453, 103718, 103919, 104471, 105034, 105282, 105427, 105567, 105996, 106960, 108658, 112024, 112530
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    CA, CT, FL, GA, IL, MO, NJ, NY, NC, OH, PA, RI, VA , Puerto Rico, Australia, Belgium, Canada, Columbia, Czech, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Jordan, Malaysia, Malta, Netherlands, Norway, Rwanda, Saudi Arabia, Sweden, Switzerland, United Kingdom, and Vietnam
  • Description du dispositif
    Oxygen Masks, Elongated (under chin), Adult Med Conc., No Tubing, Product Code 104-E;
  • Manufacturer
    ConvaTec, Inc

Manufacturer

ConvaTec, Inc
  • Adresse du fabricant
    ConvaTec, Inc, 7900 Triad Center Dr Ste 400, Greensboro NC 27409-9076
  • Société-mère du fabricant (2017)
    Triona Holding Sa
  • Source
    USFDA