Events

Rappel de Device Recall Luma Wrap

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
    68803
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2181-2014
  • Date de mise en oeuvre de l'événement
    2014-07-11
  • Date de publication de l'événement
    2014-08-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128768
  • 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
    blanket, neonatal phototherapy - Product Code PDH
  • Cause
    Beevers manufacturing & supply inc. is recalling luma wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the us fda.
  • Action
    BMS is contacting their customers and requesting that distributors report the amount of affected product they have in stock, prior to returning affected product. BMS is also asking its distributors to forward the recall notification to its customers to whom affected product was sold. BMS expects those customers to also report to BMS the amount of affected product they have.

Device

Device Recall Luma Wrap
  • Modèle / numéro de série
    Recalled units include: LW102 (medium), Lot 66812; LW103 (large), Lots 66813 and 30660; and  LW105 (extra large), Lot 67879.  LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
  • Description du dispositif
    Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
  • 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