Events

Rappel de Device Recall Care Cliner

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
    61457
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1460-2012
  • Date de mise en oeuvre de l'événement
    2012-02-06
  • Date de publication de l'événement
    2012-04-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-07-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108146
  • 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
    Winco manufacturing llc is recalling the care cliner, xl care cliner, drop arm care cliner, elite care cliner, and xl elite care cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. certain 5" nylon casters shipped with the chairs may be defective. there is a potential of the caster's axle working itself out of the assembly under unconventional conditions. should this.
  • Action
    Winco Mfg. sent an "URGENT DEVICE RECALL" letter dated February 1, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were asked to complete the Caster Recall Replacement Form and return it to the firm's Customer Service Department via fax to 352-854-9544. Contact the Customer Service Department at 800 237-3377 for questions regarding this notice.

Device

Device Recall Care Cliner
  • Modèle / numéro de série
    Model 6940, 6950.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Canada and Singapore.
  • Description du dispositif
    ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part: "****ELITE CARE CLINER 6940/6950***Winco***ISO 9001-2008 Certified***Hassle-free design to optimize your patients comfort***This Elite Care Cliner features dual swing-arms, allowing patients with limited mobility a modified entry. Also, LiquiCell has been added into the seat for extra comfort. This ultra-thin, liquid-filled interface aids in improved blood flow, and helps prevent skin breakdown.***HEAT MASSAGE(Optional)***KEY FEATURES***Dual side swing-arms for modified entry and ease of cleaning***Dual fold down tables***LiquiCell for added comfort***5" nylon total-lock casters***Built-in headrest***Headrest cover***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". || Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" || The Care Cliner is 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