Events

Rappel de Stopcock

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 ICU Medical, 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
    62538
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2128-2012
  • Date de mise en oeuvre de l'événement
    2012-04-17
  • Date de publication de l'événement
    2012-08-02
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-08-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110875
  • 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
    Catheter, intravascular, diagnostic - Product Code DQO
  • Cause
    The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
  • Action
    ICU Medical sent an Urgent Medical Device Recall letter dated April 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to inspect inventory, destroy affected products according to hospital protocol, complete and return verification form and contact ICU Customer Service to order replacement products. The letter states that ICU Medical will credit customer for any product destroyed once the completed verification form is received. This recall should be carried out to the user level and passed on to all those who need to be aware within your organization or any other organization the device may have been transferred to. Should you have any questions or require assistance relating to this recall please contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: customerservice@icumed.com

Device

Stopcock
  • Modèle / numéro de série
    Part Number 423530401 510(k) K052865 Lot#s: 2432974, 2441508, 2448504, 2455568
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution
  • Description du dispositif
    High Pressure Stopcock (3-Way, Luer Lock, Off). || Product Usage: || For IV.
  • Manufacturer
    ICU Medical, Inc.

Manufacturer

ICU Medical, Inc.
  • Adresse du fabricant
    ICU Medical, Inc., 951 Calle Amanecer, San Clemente CA 92673-6212
  • Société-mère du fabricant (2017)
    ICU Medical, Inc.
  • Source
    USFDA