Events

Rappel de Device Recall Port/PICC Access Kit

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 Centurion Medical Products.

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
    57661
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1018-2011
  • Date de mise en oeuvre de l'événement
    2010-12-06
  • Date de publication de l'événement
    2011-02-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-02-16
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96985
  • 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
    Kit, i.V. Start - Product Code LRS
  • Cause
    The firm is conducting a recall of kits that contain the monoject prefill advanced flush syringes containing heparin. the syringes are under recall by their manufacturer coviden because of testing that showed "that the crude heparin used to produce a specific batch of purified heparin sodium usp contained low level of over-sulfated chondroitin sulfate (oscs)".
  • Action
    The firm, Covidien, sent an "URGENT PRODUCT RECALL" letter dated November 12, 2010, to affected customers via Certified Mail, Return Receipt Requested. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to examine their inventory and in-use stock to determine if they have any units of the affected product, if found, immediately remove from inventory and quarantine; if they are a distributor they were ask to notify their customers of this letter; and complete and return the PRODUCT RECALL FORM whether or not they have the affected product via fax to: 203-822-6009 or scan and email to: sdfeedback@covidien.com. Note: The returned product will be collected and counted prior to destruction or return to the vendor. Should you have any medical questions concerning this recall, please call 508-261-6393. For Customer Service questions regarding the recall, please use one of the following methods: phone 1-800-962-9888 option 1 (8am to 6:30pm Eastern); email: sdfeedback@covidien.com or fax: 302-822-6009.

Device

Device Recall Port/PICC Access Kit
  • Modèle / numéro de série
    2010032280, 2010051080 and 2009122880.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution: USA including states of: OH, WI, IL, MO and TX.
  • Description du dispositif
    Port/PICC Access Kit, Reorder CV13240, Sterile, Centurion Medical Products Corp. Williamston, MI || Intended use: Vascular access port kit
  • Manufacturer
    Centurion Medical Products

Manufacturer

Centurion Medical Products
  • Adresse du fabricant
    Centurion Medical Products, 301 Catrell Dr, Howell MI 48843-1703
  • Société-mère du fabricant (2017)
    Medline Industries Inc.
  • Source
    USFDA