Events

Rappel de Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate

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 Medical Care Holdings, 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
    58736
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-2551-2011
  • Date de mise en oeuvre de l'événement
    2011-03-23
  • Date de publication de l'événement
    2011-06-10
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-09-12
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100194
  • 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
    Dialysate concentrate for hemodialysis (liquid or powder) - Product Code KPO
  • Cause
    Mislabeled: incorrect lot number printed on case labels.
  • Action
    Fresenius sent an CUSTOMER NOTIFICATION LETTER letter dated April 18, 2011, to all affected customers via Certified Mail, Return Receipt Requested. Fresenius also contacted affected customers by telephone April 18, 2011, The letter identified the product, the problem and the action needed to be taken by customer. Customers were instructed to examine their stock to determine whether they have the incorrect case label and are asked to remove the correctly labeled product from the incorrectly labeled case and discard the case. Acknowledgement forms were Fax-back forms for clinics and mail-back forms (including self-addressed, stamped envelopes), for home patients. Question or concerns should be directed to Fresenius Customer Service Team at 1- 800.323.5188.

Device

Device Recall NaturaLyte Sodium Bicarbonate Liquid Concentrate
  • Modèle / numéro de série
    Lot Number: 11 BMLB005 (Incorrect Lot Number: 11 BLMB005)
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution--AL, CA, CT, FL, GA, NJ, NV, NY, OR, PA, and WA
  • Description du dispositif
    Naturalyte@ Sodium Bicarbonate Liquid Concentrate, Dialysate Concentrate for Hemodialysis Liquid || Part number: 08-4000-LB || Formulated to be used with a three stream hemodialysis machine which is calibrated for acid and bicarbonate concentrates
  • Manufacturer
    Fresenius Medical Care Holdings, Inc.

Manufacturer

Fresenius Medical Care Holdings, Inc.
  • Adresse du fabricant
    Fresenius Medical Care Holdings, Inc., 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA