Events

Rappel de Device Recall Drainer(R) Centesis Catheters

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 Vascular Solutions, 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
    80135
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2249-2018
  • Date de mise en oeuvre de l'événement
    2018-05-04
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164661
  • 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
    Accessories, catheter - Product Code KGZ
  • Cause
    The supplier of drainer(r) centesis catheters notified vascular solutions, inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
  • Action
    Galt Medical Corp. sent an Urgent Medical Device Recall dated May 2, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. The firm requested the following actions be taken: Those with affected stock, were directed to immediately discontinue use and quarantine any product. If the affected product was further distributed, the distributor was directed to immediately contact all parties who may have received the affected stock and recover any unused product. For questions contact your local sales representative or Recall Coordinator at 214-778-1306 or email quality@galtneedletech.com

Device

Device Recall Drainer(R) Centesis Catheters
  • Modèle / numéro de série
    a) REF 8810, 5F x 9cm, Lot Numbers: 18037128, 18057123 (b) REF 8811, 6F x 9cm, Lot Numbers: 18026062, 18026063 (c) REF 8812, 5F x 15cm, Lot Number: 18050076
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    1
  • Dispositif implanté ?
    No
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Drainer(R) Centesis Catheters: || (a) REF 8810, 5F x 9cm || (b) REF 8811, 6F x 9cm || (c) REF 8812, 5F x 15cm || Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Adresse du fabricant
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA