Events

Rappel de Device Recall Coseal Surgical Sealant

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 Baxter Bioscience.

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
    55825
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1949-2010
  • Date de mise en oeuvre de l'événement
    2010-01-14
  • Date de publication de l'événement
    2010-07-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2010-12-22
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92111
  • 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
    Polymerizing Sealant - Product Code NBE
  • Cause
    The recall is being conducted as a precautionary measure due to out of specification results at the 18 month and 21 month time points (out of the 24 month licensed shelf life to expiration) for the percent thiol substitution during a coseal stability study. the parameter that is out of specification is an indicator of possible failure for the product to gel appropriately.
  • Action
    The recall notification was initiated on January 14, 2010 with the firm sending a Product Recall letter and attached Customer Reply Form to the affected consignees. The recall letter informed the consignees of the reason for recall and requested them to immediately stop the usage/distribution of the lots noted above and to quarantine any units you may still have in your inventory. The letter provided instruction for product return. The letter also requested the consignees to please forward the recall information as appropriate to other services/facilities/departments that they may have provided this product to. Consignees were instructed to complete the Customer Reply Form, and fax it as soon as possible to 888-345-4261. Consignees with questions were instructed to contact Stericycle at 877-870-4486.

Device

Device Recall Coseal Surgical Sealant
  • Modèle / numéro de série
    Lot Numbers: HA080942, HA080943, HA081001E, HA081046E, HA081102, HA081132, HA081235, HA090139, HA090241, & HA090342.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Coseal Surgical Sealant 4mL, Product Codes: 934071 & 934074. || Indicated for use in vascular reconstructions to achieve adjunctive hemostasis.
  • Manufacturer
    Baxter Bioscience

Manufacturer

Baxter Bioscience
  • Adresse du fabricant
    Baxter Bioscience, 1 Baxter Way, Westlake Village CA 91362-3811
  • Société-mère du fabricant (2017)
    Baxter International
  • Source
    USFDA