Events

Rappel de Ethicon

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 Ethicon, 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
    62056
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1897-2012
  • Date de mise en oeuvre de l'événement
    2012-04-03
  • Date de publication de l'événement
    2012-06-27
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-04-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109783
  • 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
    Agent, absorbable hemostatic, collagen based - Product Code LMF
  • Cause
    The lyophilized thrombin component of the surgiflo hemostatic matrix kit with thrombin has the potential to be non-sterile due to an undetected air leak which occurred during the manufacturing process.
  • Action
    Ethicon Inc. sent a Urgent Voluntary Product Recall letter dated April 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you have any product subject to this voluntary recall, please remove it from your inventory immediately and return it per the following instructions. Return product to Stericycle using the enclosed pre-paid shipping label. Shipping fees wil be charged directly to Ethicon through the use of this shipping label. No reimbursements will be made for the shipping charge if this label is not used. Extra shipping labels may be obtained by calling 1-866-338-2611. Credit will be issued for impacted product that is returned. Further questions please call 1-866-338-2611, or contact your Ethicon Biosurgery Sales Representative. Thank you for your coorporation and immediate assistance. .

Device

Ethicon
  • Modèle / numéro de série
    D100622   Product Code Lot Number Expiration Date  199102S 237115 8/31/2012 199102S 238568 9/30/2012 199102S 238569 11/30/2012 199102S 237493 6/30/2012 2993 235489 11/30/2012 2993 238599 3/31/2013 2993SAMP 238369 3/31/2013 SAMP199102S 237493 6/30/2012 SAMP199102S 283569 11/30/2012
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    USA (nationwide)
  • Description du dispositif
    Ethicon Surgiflo Hemostatic Matrix Kit with Thrombin Plus Flex Tip || Distributed by Ethicon Ethicon Inc., Somerville, NJ 08876 USA || Manufactured by Ferrosan Medical Devices || Ferrosan Medical Devices A/S || Sydmarken 5, DK-2860 Soeberg, Denmark || Mixed with sterile saline or thrombin solution is indicated for surgical procedures (except opthalmic) for hemostasis when control of capillary, venous and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical.
  • Manufacturer
    Ethicon, Inc.

Manufacturer

Ethicon, Inc.
  • Adresse du fabricant
    Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
  • Société-mère du fabricant (2017)
    Johnson & Johnson
  • Source
    USFDA