Events

Rappel de Winco Care Cliner XLarge with Nylon Casters

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 Winco Mfg., LLC.

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
    71496
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2393-2015
  • Date de mise en oeuvre de l'événement
    2015-04-02
  • Date de publication de l'événement
    2015-08-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137968
  • 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
    Chair, adjustable, mechanical - Product Code INN
  • Cause
    Shipment of foam for chairs was received classified as fire retardant but was in fact standard foam and would not meet fire retardant standards.
  • Action
    Winco sent a field correction letter dated April 2, 2015, to all affected customers The letter identified the product, the problem, and the action to be taken by the customer. Winco instructed customers that they will replace the recliners at no charge to the customer. Winco will provide detailed instructions for the replacement of the seats by their facility staff. Winco will extend the remaining warranty on the entire chair for a period of 6 months as compensation. If product was further distributed customers were instructed to notify those customers of the field correction. Customers were asked to complete and return the enclosed field correction response form as soon as possible. Customers with questions should contact Customer Care Monday-Friday 8:30 AM-5:00 PM EST at 800-237-3377 or email QA-RA@wincomfg.com. For questions regarding this recall call 352-854-2929.

Device

Winco Care Cliner XLarge with Nylon Casters
  • Modèle / numéro de série
    Model Number: 6540
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, FL, KS, KY, LA, MA, MD, MN, MS, NJ, NY, OK, TN, TX, and WA.
  • Description du dispositif
    Winco Care Cliner X-Large - with Nylon Casters || Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician Facilities.
  • Manufacturer
    Winco Mfg., LLC

Manufacturer

Winco Mfg., LLC
  • Adresse du fabricant
    Winco Mfg., LLC, 5516 SW 1st Ln, Ocala FL 34474-9307
  • Société-mère du fabricant (2017)
    Winco Mfg. Llc
  • Source
    USFDA