Events

Rappel de Device Recall Genzyme

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 Genzyme Corporation.

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
    62127
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1855-2012
  • Date de mise en oeuvre de l'événement
    2012-06-13
  • Date de publication de l'événement
    2012-06-21
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-07-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109887
  • 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
    Barrier, absorable, adhesion - Product Code MCN
  • Cause
    Sterility of product may be compromised due to packaging defect.
  • Action
    Genzyme issued an Urgent: Medicatical Device Product Recall Notification Letter dated June 13, 2012 to all affected customers. Stericycle Expert Solutions, will be acting on behalf of Genzyme to coordinate notifications, communications, and logistics for returns of all product subject to this recall. The letter identified the affected products, problen and actions to be taken. Customers are requested to check their inventory and return all affected products per the instructions provided. Customers are instructed to complete the enclosed Business Reply Form and return via fax transmission to 866-912-2519. For questions call Stericycle at: 877- 473-7069.

Device

Device Recall Genzyme
  • Modèle / numéro de série
    Lot numbers: 11NP620 Exp. 2014 - 09; 11NP630 Exp 2014 - 10; and 11NP649 Exp 2014- 11; 11NP704 Exp 2014 - 11
  • Classification du dispositif
    Obstetrical and Gynecological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide) and the country of S. Korea
  • Description du dispositif
    seprafilm¿ Procedure Pack ADHESION BARRIER || Re-order Number: 5086-02 || Product Usage: || Seprafilm Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.
  • Manufacturer
    Genzyme Corporation

Manufacturer

Genzyme Corporation
  • Adresse du fabricant
    Genzyme Corporation, 31,45,49,51,55,74,76, & 80 New York Ave., Framingham MA 01702-5733
  • Société-mère du fabricant (2017)
    Sanofi
  • Source
    USFDA