Events

Rappel de Device Recall Universal Quick Adjust

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 Medical Depot 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
    73918
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2104-2016
  • Date de mise en oeuvre de l'événement
    2016-02-17
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2018-06-13
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145416
  • 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
    Tips and pads, cane, crutch and walker - Product Code INP
  • Cause
    Tip crutch failure involving the bottom of the metal portion which comes in contact with ground.
  • Action
    On February 17, 2016, drive DeVilbiss Healthcare issued a preliminary notice their customers informing them of the situation via courier service. Secondly, On February 25, 2016, drive DeVilbiss Healthcare distributed another notice informing customers that the potential issue was confirmed to a limited number of lots. Customers were advised to quarantine all products in inventory as replacement products will be provided. The company notified customers that they will commence shipping orders for the product on Monday, February 29, 2016. Customers were also advised that a substantial inventory of replacement crutch tips for distribution will begin on or about March 7, 2016. On March 11, 2016, drive DeVilbiss distributed a third notice to their customers via courier service advising them of customer reimbursement for time and labor costs associated with this action. Drive Devilbiss Healthcare will reimburse based on the total number of tips requested to be shipped. Lastly, on May 12, 2016, drive DeVilbiss distributed a fourth Urgent Medical Device notice and response form to their customers via email. drive DeVilbiss advised customers to: 1) quarantine any stock that has not been inspected already and compare serial numbers of stocks to list provided, 2) any product received after 3/7/16 has been fully inspected and has an approved crutch tip that is free of defect, 3) if products were further distributed, contact those customers who received product between 7/2015 to 12/2015 and determine if items are still being used, 4) If the customer is still using this item, contact your sales representative so the return and replacement of this product can be processed and 5) complete and return the response form vial email. Customers with questions can contact by telephone 516-998-4600 ext. 4422.

Device

Device Recall Universal Quick Adjust
  • Modèle / numéro de série
    Item #: 1) RTL 10400, 2) RTL 10402
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case || Aid the user in walking while relieving weight from one foot or leg.
  • Manufacturer
    Medical Depot Inc.

Manufacturer

Medical Depot Inc.
  • Adresse du fabricant
    Medical Depot Inc., 99 Seaview Blvd Fl 2, Port Washington NY 11050-4606
  • Société-mère du fabricant (2017)
    Medical Depot Inc.
  • Source
    USFDA