Events

Rappel de Device Recall PROFlex Transporter, model 35PST.

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 Ferno-Washington 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
    34010
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0201-06
  • Date de mise en oeuvre de l'événement
    2003-03-28
  • Date de publication de l'événement
    2005-11-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2008-10-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42904
  • 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
    Stretcher, Wheeled - Product Code FPO
  • Cause
    The firm received complaints of the stretchers folding. a fold is when the stretcher lowers on its own to either the next position, or any of the other seven postions of the stretcher.
  • Action
    The firm went out to customers who had complained of a 'fold' and installed the kit on the stretcher that had experienced the fold and on all other PROflexx stretchers owned by the customer. These customers had received a recall letter, dated March 28, 2003. For customers that had not complained of the stretchers 'folding', the firm sent a letter dated June 24, 2003, to all distributors requesting the distributor provide the firm with a list of customers that had received the PROflex stretchers. Once the firm had a list of all customers, they sent them a letter offering them the kit as an enhancement that they could purchase to help reduce the possibility of false locking.

Device

Device Recall PROFlex Transporter, model 35PST.
  • Modèle / numéro de série
    All stretchers containing a serial number beginning with the letter ''L'' and followed by a sequence of six numbers.
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    The product was distributed nationwide to 27 states: TN, MA, VT, IL, KY, NY, SC, WI, TX, MO, NH, CO, GA, NC, CA, VA, IA, PA, CT, OH, NJ, ID, WV, AL, AR, ME and IN.
  • Description du dispositif
    PROFlex Transporter, Model numbers 35PST. The catalog number for the model 35PST is PT3565.
  • Manufacturer
    Ferno-Washington Inc

Manufacturer

Ferno-Washington Inc
  • Adresse du fabricant
    Ferno-Washington Inc, 70 Weil Way, Wilmington OH 45177-9371
  • Société-mère du fabricant (2017)
    Ferno-Washington Inc.
  • Source
    USFDA