Events

Rappel de Device Recall Cannulaide

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 Beevers Manufacturing & Supply, 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
    69627
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0483-2015
  • Date de mise en oeuvre de l'événement
    2008-05-13
  • Date de publication de l'événement
    2014-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-11-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131194
  • 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
    Ventilator, non-continuous (respirator) - Product Code BZD
  • Cause
    Cannulaide recalled may 2008 due to improper seal of the pouch. the improper seal of the cannulaide's package could potentially affect the device shelf life.
  • Action
    Beevers Manufacturing & Supply, Inc. (BMS) did contact the customers via letter and phone call in May 2008. Customers that didn't reply were further contacted via email on June 2008. Salter Labs provided BMS' recall report to FDA in October 2014. Salter Labs was unable to locate a recall letter issued by BMS to the affected customers. For further questions please call (503) 472-9055

Device

Device Recall Cannulaide
  • Modèle / numéro de série
    CA 101: Lot 54219; CA 102: Lot 52834; CA 103: Lot 53813;
  • Classification du dispositif
    Anesthesiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Distribution including the states of LA, GA, OR, MA, NJ, FL and CA., and the countries of Canada, France, Japan, Netherlands and United Kingdom.
  • Description du dispositif
    Cannulaide, Model 101, 102, 103. Respirator. || The Cannulaide product is composed of die-cut hydrocolloid-coated polyurethane film with an integral hook strip (i.e., Velcro) to allow for the use of a loop material to help secure a nasal interface. || The Cannulaide is applied under and over the nose of infants to provide a protective barrier to the philtrum, columella, septum, nares, and tip of nose. || It is available in multiple sizes that vary the external geometry and nare hole size and spacing to allow for use on infants ranging from less than 700 grams to greater than 3000 grams. It is a non-sterile, single patient use, disposable device.
  • Manufacturer
    Beevers Manufacturing & Supply, Inc.

Manufacturer

Beevers Manufacturing & Supply, Inc.
  • Adresse du fabricant
    Beevers Manufacturing & Supply, Inc., 850 SW Booth Bend Rd, McMinnville OR 97128-9320
  • Société-mère du fabricant (2017)
    Beevers Manufacturing & Supply Inc.
  • Source
    USFDA