Events

Rappel de Device Recall Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip

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 Microline Surgical, 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
    59469
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3086-2011
  • Date de mise en oeuvre de l'événement
    2011-07-18
  • Date de publication de l'événement
    2011-08-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-09-09
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102847
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Cause
    Mislabeled: renew product number 3262 (long fenestrated grasper) was packaged and labeled as product number 3642 (super-atrau fenestrated grasper). renew product number 3642 (super-atraumatic fenestrated grasper) was packaged and labeled as 3262 (long fenestrated grasper.
  • Action
    Microline Surgical sent a RECALL NOTICE letter dated July 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine product subject to the recall. If customers further distributed the product, customers should identify their accounts and notify them immediately of the product recall. Customers were instructed to contact Microline Customer Service to obtain a Return Authorization Number for return of the recalled item. Customers were asked to complete and return the enclosed Recall Return Response Form as soon as possible. For any questions customers were instructed to call the Regulatory Affairs Manager at 978-867-1726.

Device

Device Recall Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper For...
  • Modèle / numéro de série
    Lot Number: 00105709 Expiration date: 5-2016
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.
  • Description du dispositif
    Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip || Ref: 3642 || The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula
  • Manufacturer
    Microline Surgical, Inc.

Manufacturer

Microline Surgical, Inc.
  • Adresse du fabricant
    Microline Surgical, Inc., 800 Cummings Ctr Ste 166t, Beverly MA 01915-6171
  • Société-mère du fabricant (2017)
    HOYA Corp.
  • Source
    USFDA