Events

Rappel de Device Recall Bath Safe Adjustable Shower Seat With Back

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 Nutech Manufacturing Corp.

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
    53161
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0461-2010
  • Date de mise en oeuvre de l'événement
    2009-07-09
  • Date de publication de l'événement
    2009-12-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-05-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85904
  • 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
    Transfer Aid - Product Code IKX
  • Cause
    Safety chair used in shower/bath may not meet specifications for weight load.
  • Action
    The subsidiary distributor, Maddak, Inc. notified customers by A "Voluntary Product Recall Notice", phone and e-mail on 07/09/2009. The own label distributor instructed customers to return their inventory of affected products received between May 1, 2009 and July 7, 2009. Distributors were instructed to immediately quarantine then return all affected inventory to Maddak and notify their accounts. Distributors were requested to instruct dealers to display a "storefront" notice and provide consumers with a customer response form. Distributors were also requested to forward a request to dealers to post a website notice if they have one. Recovered products will be replaced.

Device

Device Recall Bath Safe Adjustable Shower Seat With Back
  • Modèle / numéro de série
    Device is not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 are being recalled.
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution -- USA and Canada.
  • Description du dispositif
    Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101
  • Manufacturer
    Nutech Manufacturing Corp

Manufacturer

Nutech Manufacturing Corp
  • Adresse du fabricant
    Nutech Manufacturing Corp, 2024 Broad Street, PO Box 840, Pocomoke City MD 21851-0840
  • Source
    USFDA