Events

Rappel de Baxter Clearlink System Luer Activated Universal VIal Adapter

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 Healthcare 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
    29014
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0194-05
  • Date de mise en oeuvre de l'événement
    2004-04-28
  • Date de publication de l'événement
    2004-11-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2007-02-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32978
  • 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
    Set, Administration, Intravascular - Product Code FPA
  • Cause
    Inadequate directions for use may have contributed to an increase in infection rates at a small number of customers beginning use of the clearlink needleless device.
  • Action
    An Urgent Device Correction letter and reply form dated 4/28/04 were sent to all U.S. Clearlink customers, informing them of the reports of increased infection rates abd describing the revision of the product labeling with additional statements that relate to product usage and reinforcement of standard clinical practices and proper aseptic technique. The revised labeling statements are as follows: * Ensure clamp is open. Swab Luer activated surface with preferred antiseptic prior to first use and before every subsequent connection. * Don not swab Luer activated surface when clamp is closed or valve is recessed. Ineffective swabbibg may result. Replace if valve remains recessed. * Flush Luer activated valve after blood infusion/sampling. If valve cannot be cleared of blood, replace immediately. * Luer lock vacutainer holders, syringes and accessories are recommended for blood sampling. If blood remains on valve surface after sampling, swab surface. * If intermittently disconnecting set from Luer activated valve, immediately cover male Luer with a sterile replacement protector.

Device

Baxter Clearlink System Luer Activated Universal VIal Adapter
  • Modèle / numéro de série
    product code 2N8395, all lots
  • Classification du dispositif
    General Hospital and Personal Use Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide, and internationally through Baxter subsidiaries to Macedonia, Nigeria, Saudi Arabia, South Africa, Ireland, Italy, Denmark, Germany, the Netherlands, Hong Kong, Indonesia, Singapore, Spain, Belgium, Norway, United Kingdom, France and Luxembourg.
  • Description du dispositif
    Baxter Clearlink System Luer Activated Universal VIal Adapter, product code 2N8395; Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Adresse du fabricant
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA