Events

Rappel de Device Recall GelE Donut, Squishon 2

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 Childrens Medical Ventures.

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
    68443
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2192-2014
  • Date de mise en oeuvre de l'événement
    2014-05-28
  • Date de publication de l'événement
    2014-08-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-11-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127715
  • 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
    Protector, skin pressure - Product Code FMP
  • Cause
    The gel-filled gel-e donut and squishon product line has received a number of complaints about visible mold. the mold detected was determined to be cladosporium and penicillium fungi, which are commonly found molds.
  • Action
    Childrens Medical Ventures sent an Urgent Medical Device Recall letter dated May 28, 2014, to affected customers via UPS. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to review entire inventory and inspect for signs of visible mold, do not open the packaging to do the inspection, the mold should be seen through the transparent outer packing, complete and return the reply form provided on the last page of the letter, dispose of any product containing mold per your facilitys environmental guidelines, do not return any product to your Distributor or to Philips/Childrens Medical Ventures.and credit for disposed product will be given. If you need any further information or support concerning this problem, please contact your Distributor at the following phone number:

Device

Device Recall GelE Donut, Squishon 2
  • Modèle / numéro de série
    All lots of models: 92025-A, 92025-B, 92025-C, 91033-2
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including the country of Canada.
  • Description du dispositif
    Gel-E Donut, Squishon 2 gel pillows || Product Usage:: The products are intended to support and cradle a baby s head and/or body. The rectangular shape of the Squishon product allows for head movement while maintaining a supportive surface and provides an effective ventral support for prone positioning. The round shape of the Gel-E Donut products help alleviate pressure caused by prolonged immobility or other conditions where frequent repositioning is contraindicated.
  • Manufacturer
    Childrens Medical Ventures

Manufacturer

Childrens Medical Ventures
  • Adresse du fabricant
    Childrens Medical Ventures, 191 Wyngate Dr, Monroeville PA 15146-3045
  • Source
    USFDA