Events

Rappel de Designer Care Cliner 6700/6704/6710

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
    63651
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0780-2013
  • Date de publication de l'événement
    2013-02-04
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114735
  • 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, with casters - Product Code INM
  • Cause
    The performance of the chemicals in the foam and vinyl are not consistent enough to meet the tb 133 fire protection mandate required by california and 4 other states.
  • Action
    Winco sent a Chair Field Correction Notification dated September 24, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to forward the "Field Correction Form - REPAIR" form back to Winco and the firm would send a Winco Representative to the consignees' facility to correct the chairs in the field. Customers with questions were instructed to contact Winco at 800-237-3377 or email customerservice@wincomfg.com. For questions regarding this recall call 352-854-2929, ext 110.

Device

Designer Care Cliner 6700/6704/6710
  • Modèle / numéro de série
    Model 6700, 6704 and 6710.  Serial numbers: 670A100027, 670A100028, 670A100323, 670100082, 670100083, 670A100101, 670A100021, 670A100324, 670A100325, 670A100284, 670A100242, 670100005, 670100124, 670100125, 670100181, 670100182, 670100183, 670100184, 670100185, 670100186, 670100026, 670A100004, 670A100036, 670A100037, 670A100038, 670A100039, 670A100040, 670A100041, 670A100042, 670A100043, 670A100044, 670A100124, 670A100135, 670A100138, 670A100137, 670A100278, 670A100299, 670A100308, 670A100345, 670A100365, 670A100191, 670A100243, 670A100303, 670100027, 670100193, 670A100244, 670A100245, 670A100246, 670100018, 670100022, 670100021, 670100020, 670100175, 670100176, 670100177, 670100171, 670100187, 670100188, 670100189, and 670100190
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution including CA, FL, IL, MA, MD, MN, NM, NY, OH, OK, and TX.
  • Description du dispositif
    Designer Care Cliner 6700/6704/6710 || WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
  • 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