Events

Rappel de Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)

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 Fresenius Kabi, LLC.

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
    58596
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2199-2011
  • Date de mise en oeuvre de l'événement
    2011-04-19
  • Date de publication de l'événement
    2011-05-16
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-12-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99655
  • 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
    Separator, automated, blood cell and plasma, therapeutic - Product Code LKN
  • Cause
    Operating manual of the as 104 blood cell separator is being updated to eliminate any reference to red blood cell (rbc), c4y, p1y and bmsc sets. this is a corrective action and recall expansion of z-0616-2011.
  • Action
    Fresenius Kabi sent a "Urgent Notification" letter dated May 6, 2011, to the affected consignees they are recalling the Operating Manual for the Fresinius AS104-Blood Cell Separator. The Red Blood Cell (RBC) sets have been recalled according to recall number Z-0616-2011, and will permanently not be used with the AS 104 Blood Cell Separator Device. The RBC set was never approved by the FDA according to Warning Letter (Reference # GEN1001508) dated 31 January 2011. The customers are being instructed to complete the self addressed postage pre-paid " Product Response Card." Place a check mark next to the disposition choice used. Fresenius plans to send the revised Operating Manual and a notification letters to consignees at the end of April 2011. Consignees who have questions about this recall can call the firm at 1-425-242-2074.

Device

Fresenius AS 104 Blood Cell Separator 2/03.11 (OPUSA)
  • Modèle / numéro de série
    The manual contains the operating instructions for AS 104 Blood Cell Separator and has a Software Version 4.71.   The AS104 Blood Cell Separator Device has a Catalog Number 9007031.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    Unclassified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwided Distribution -- AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MI, MN, NC, NH, NJ, NM, NY, OH, PA, SD, TN, TX, VT, and WI.
  • Description du dispositif
    The Operating Manual contains the Operating Instructions for AS 104 Blood Cell Separator and has a Software Version 4.71. The AS 104 Blood Cell Separator Device has a Catalog Number 9007031. || Used for depletion or exchange of red blood cells during therapeutic apheresis procedures on the Fresenius AS 104 Blood Cell Separator Device. This set is used with a single stage separation chamber.
  • Manufacturer
    Fresenius Kabi, LLC

Manufacturer

Fresenius Kabi, LLC
  • Adresse du fabricant
    Fresenius Kabi, LLC, 8635 154th Ave NE, Redmond WA 98052-3564
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA