Events

Rappel de Superstat Modified Collagen Hemostatic Sponge

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 Superstat Corp.

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
    63581
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0339-2013
  • Date de mise en oeuvre de l'événement
    2012-10-24
  • Date de publication de l'événement
    2012-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-02-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114275
  • 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 recall was initiated because superstat corporation has confirmed that no documentation are available to verify that quarterly dose sterility audits were performed for the superstat modified collagen hemostatic sponge.
  • Action
    Superstat initially contacted customers by telephone and sent an Urgent - Device Recall Notification Letter on October 24, 2012, to all affected customers. The recall letter provided the reason for recall was due to inadequate documentation of quarterly dose sterility audits. The recall includes all lots and part numbers of Superstat produced between 2002 and 2012. Customers are instructed to complete and return the enclosed response form as soon as possible. Customers with questions are instructed to call customer service at (800) 487-3786. For questions regarding this recall call 310-605-1655.

Device

Superstat Modified Collagen Hemostatic Sponge
  • Modèle / numéro de série
    Lot# SSK02D, SSK05D.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Saudi Arabia, Thailand, Mexico, Canada, Pakistan, Israel, Greece, Serbia, Canda, Isle of Man, Nova Scotia, and Singapore.
  • Description du dispositif
    Superstat Modified Collagen Hemostatic Sponge, 32mm Disc, 1.5%, Part# 9120-15, 9100-15. || For use when hemostasis is desired along suture lines, in diffusely bleeding sites, in incisions, dissections, and around arterial or venous anastomoses. Indicated in oozing bleeding, either capillary or venous, in almost all types of incisions or wounds, and as an adjunct to conventional closure techniques
  • Manufacturer
    Superstat Corp

Manufacturer

Superstat Corp
  • Adresse du fabricant
    Superstat Corp, 2015 E University Dr, Rancho Dominguez CA 90220-6411
  • Société-mère du fabricant (2017)
    Superstat Corp
  • Source
    USFDA