Events

Rappel de Device Recall Re Turn

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 Handicare USA, 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
    70995
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1613-2015
  • Date de mise en oeuvre de l'événement
    2015-03-26
  • Date de publication de l'événement
    2015-05-14
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-17
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135822
  • 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
    Aid, transfer - Product Code IKX
  • Cause
    Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force was applied.
  • Action
    Handicare sent an Voluntary Product Recall Notification letter dated April 2, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were requested to quarantine any remaining stock and to contact customers if product was further distributed and to return the affected product for a replacement and/or full refund. Also, enclosed is a response form. Please complete and return the form even if you do not have any product to return. Your Sales representative can assist you in completing this form. This information is essential in order to maintain recall effectiveness information (required by FDA). Thank you for your support. We are committed to re-releasing the wipeable ReTurn belt as soon as we believe that it meets the quality standards that you expect from Handicare. Please contact our Customer Experience team at 1-866-276-5438 if you have any questions regarding the recall or would like assistance with the recall. We regret any inconvenience that this action may cause, but we appreciate your understanding as we take action to ensure patient and customer satisfaction.

Device

Device Recall Re Turn
  • Modèle / numéro de série
    All affected product in the U.S are from the same LOT #1402S, Model #s 6133-6136
  • Classification du dispositif
    Physical Medicine Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : FL, CA, NJ, NC and MD.
  • Description du dispositif
    ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
  • Manufacturer
    Handicare USA, Inc.

Manufacturer

Handicare USA, Inc.
  • Adresse du fabricant
    Handicare USA, Inc., 2201 Hangar Pl, Ste 200, Allentown PA 18109-9342
  • Société-mère du fabricant (2017)
    Handicare Group Ab
  • Source
    USFDA