Events

Rappel de Device Recall LifeLiner

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 DePuy Orthopaedics, 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
    65078
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1331-2013
  • Date de mise en oeuvre de l'événement
    2013-05-08
  • Date de publication de l'événement
    2013-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117845
  • 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
    Dress Surgical - Product Code FYE
  • Cause
    Lifeliner stick and cut resistant gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove packaging containing left handed, large sized gloves.
  • Action
    DePuy Synthes Joint Reconstruction, a division of DePuy Orthopaedics, Inc.,sent a " Urgent Information Medical Device Recall Notice" dated May 8, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please cease further distribution or use of the affected gloves immediately. Our records indicate your hospital purchased the affected lot. The purpose of this communication is to inform you of this recall and request acknowledgement of receipt of this letter by signing and returning the Hospital/User Facility Reconciliation Form within 10 business days of receiving this notice. Response cards should be faxed to (574) 371-4964. Please contact your DePuy Synthes Joint Reconstruction Sales Representative for assistance returning any unused affected gloves. For product related questions, please contact your local DePuy Synthes Joint Reconstruction Sales Consultant. For clinical questions from surgeons, please contact DePuy Synthes Joint Reconstructions Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m.- 5 p.m. EDT). For questions about device recall information provided, please call (574)371-4917 (M-F; 8 a.m. - 5 p.m. EDT).

Device

Device Recall LifeLiner
  • Modèle / numéro de série
    Lot - D12178C
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) including the states of IL, OH, NC, SC, MN, NV, TN and WA., and the countries of UK, Netherlands and Canada.
  • Description du dispositif
    DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg || Part No. 5200-68-000 || The gloves are designed to resist sticks and cuts and are not cut or puncture proof. These gloves are not required by any surgical technique.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Adresse du fabricant
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA