Events

Rappel de Bassinet

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 Nemschoff Chairs, Inc..

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
    60615
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0832-2012
  • Date de mise en oeuvre de l'événement
    2011-10-14
  • Date de publication de l'événement
    2012-02-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-27
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106002
  • 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
    Bassinet, hospital - Product Code NZG
  • Cause
    To correct issues with casters, door hinges, drawer slides, and the bassinet surround. also, to add labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits.
  • Action
    The firm, Nemschoff, sent an "Important Medical Device Correction" letter and email dated October 14, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check inventory, quarantine and hold product until they receive instructions for servicing the units; once corrections are complete on the units at their locations, document all corrections on the Correction Acknowledgment Letter and return to Nemschoff, Inc. as instructed. The customers were also instructed to complete and return the enclosed Receipt Acknowledgment Form by October 21, 2011. Nemschoff will provide instructions and assistance with locating and repairing the units. If you have any questions, call Nemschoff, Inc at (800) 203-8916 and ask for our Quality Representative or your Customer Service Representative.

Device

Bassinet
  • Modèle / numéro de série
    Model BSNT/01 and BSNT/02 manufactured between 11/21/2003 and 04/04/2008. Bassinet tubs manufactured between 11/21/2003 to present.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA,MA, MD, MI, MO, MS, NC, ND, NJ, NY, OH, OK, SC, TX, VA, WA, WI, and WY; and country of: Canada.
  • Description du dispositif
    Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 || The Nemschoff Perinatal Bassinet products are wheeled carts with a top tray intended for an infant tray with mattress. The bassinets are intended for medical purposes that consist of a bed designated for the use of a pediatric patient.
  • Manufacturer
    Nemschoff Chairs, Inc.

Manufacturer

Nemschoff Chairs, Inc.
  • Adresse du fabricant
    Nemschoff Chairs, Inc., 909 N 8th St, Sheboygan WI 53081-4056
  • Source
    USFDA