Events

Rappel de Device Recall Fresenius Naturalyte Liquid Acid 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 Renal Therapies Group, 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
    73077
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0887-2016
  • Date de mise en oeuvre de l'événement
    2016-01-18
  • Date de publication de l'événement
    2016-02-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2017-08-14
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143014
  • 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
    On the label calcium (ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 meq/l ca. the concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 meq/l.
  • Action
    The firm, Fresenius Medical Care, issued an "URGENT-MEDICAL DEVICE RECALL" letter dated 1/14/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your stock for the product; if found, discontinue use immediately; place all units in a secure, segregated area; contact your FMCNA Customer Service Team at 1-800-323-5188 for instructions how to return the affected lot (lot# 15STAC072), and promptly complete and return the attached reply form by Fax to: 781-699-9796 Attn: Quality Department or scan and email to: NOTIFYRA@fmc-na.com. Fresenius will pick up and replace your product. If you have any additional medical concerns or questions, please contact Medical Information and Communication at 855-816-2309 or Website: www.fresenius-medinfo.com. Further information or support concerning this issue, contact the Customer Service Care Team at 800-323-5188 and reference the and Support Field Action Number.

Device

Device Recall Fresenius Naturalyte Liquid Acid Concentrate
  • Modèle / numéro de série
    Lot Number: 15STAC072 Exp Date: 2017-12-31
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: KS, LA, MS, OK, and TX.
  • Description du dispositif
    Fresenius Naturalyte Liquid Acid Concentrate || Catalog Number: 08-2301-3 || Intended Use: Acid Concentrate for Bicarbonate Dialysis
  • Manufacturer
    Fresenius Medical Care Renal Therapies Group, LLC

Manufacturer

Fresenius Medical Care Renal Therapies Group, LLC
  • Adresse du fabricant
    Fresenius Medical Care Renal Therapies Group, LLC, 920 Winter St, Waltham MA 02451-1521
  • Société-mère du fabricant (2017)
    Fresenius SE & Co KGaA
  • Source
    USFDA