Events

Rappel de Device Recall Ethicon Fast Absorbing Plain Gut MultiPass Needles, Sterile, Absorbable Surgical Suture

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
    71373
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1839-2015
  • Date de mise en oeuvre de l'événement
    2015-05-08
  • Date de publication de l'événement
    2015-06-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-06-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137511
  • 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
    Suture, absorbable, natural - Product Code GAL
  • Cause
    Ethicon fast absorbing surgical gut (plain) suture is being recalled because the labeling on the box and foil are incomplete.
  • Action
    Ethicon initiated this voluntary recall by sending an Urgent: Medical Device Recall (Removal) Letter/Business Reply Form (BRF) dated May 8, 2015 to their affected customers via UPS. Stericycle will be handling returns. The letters identified the affected device and the reason for the recall. Customers were asked to examine their inventory immediately to determine if they had affected devices on hand. If so, they are to remove the affected product and communicate the issue to any necessary personnel. Customers with questions were advised to contact their local sales representative or call the Customer Support Center at 1-877-384-4266. For questions regarding this recall call 908-218-0707.

Device

Device Recall Ethicon Fast Absorbing Plain Gut MultiPass Needles, Sterile, Absorbable Surgical ...
  • Modèle / numéro de série
    Product Code: 1915G (box label); 1915 (Tyvek/Foil label) Product Lot #'s JC6395, JC6417, JCK328, JCK329, JCK384, JCK716, JCM669, JCM757, JCZ987, JC5020, JC6710, JCM535, JCK330, JCK460, JCM668, JC5629 and JCM475.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- US (nationwide) and Canada.
  • Description du dispositif
    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. || Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers of the small intestine of healthy sheep, or from the serosal layers of the small intestine of healthy cattle. Fast absorbing surgical gut sutures are sterile and elecit only a slight to minimal tissue reaction during absorption.
  • 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