Events

Rappel de Central Lane, 34 weeks

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 Medline Industries 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
    71889
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2458-2015
  • Date de mise en oeuvre de l'événement
    2015-08-03
  • Date de publication de l'événement
    2015-08-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-01-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139285
  • 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
    Central venous catheter tray (kit) - Product Code OFF
  • Cause
    The print plate artwork for this lot was found to state: central line <34 weeks kit displaying an incorrect sign in front of the 34. the description for this device should have stated central line >34 weeks kit. the defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks.
  • Action
    Medline Industries contacted the account directly via phone on August 4, 2015, they confirmed no affected product is in their facility. The lot numbers are easily identified on the outside of each kit. Second and third follow up communications will not be sent as we have confirmed the facility does not have any affected product. For questions regarding this recall call 847-643-4129.

Device

Central Lane, 34 weeks
  • Modèle / numéro de série
    Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected.   Lot Numbers: 14DB9277 and 14PB2878 Unit No: DYNDC1987A Expiration Date: 06/2015  Serial No: N/A UPC code: N/A
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US including PA
  • Description du dispositif
    Central Line >34 Weeks Kit. Cardiology department. || The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Adresse du fabricant
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA