Events

Rappel de Device Recall 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
    80101
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2110-2018
  • Date de mise en oeuvre de l'événement
    2018-05-02
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164557
  • 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
    The bottles are mislabeled with an incorrect part number.
  • Action
    Phone calls and Urgent Medical Device Recall notification letters were issued on 5/2/18. Customers were instructed to do the following: Immediately examine your stock to determine whether you have any NaturaLyte Liquid Acid from the lot listed above. If any products of this lot is found, discontinue use immediately. Place all units in a secure, segregated area. Contact your FMCRTG, LLC Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product and arrange for replacement product. Promptly fill out and return the attached reply form.

Device

Device Recall NaturaLyte Liquid Acid Concentrate
  • Modèle / numéro de série
    Lot Code: 18CXAC095
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states: CA, IA, IL, IN, KS, MD, MI, MN, MS, NE, NJ, NV, OK, PA, SD, TX, and WI.
  • Description du dispositif
    NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Part Number: 08-3231-1 || Product Usage: || This concentrate is formulated to be used in conjunction with Fresenius Renal Technologies Sodium Bicarbonate Concentrate in a compatible 45X dilution three-stream artificial kidney (hemodialysis) machine. For every 45 volume parts of dialysate: 1 volume part of the NaturaLyte acid concentrate, 1.72 volume parts of FMCNA Sodium Bicarbonate Concentrate and 42.28 volume parts of Purified Water (AAMI quality) are used.
  • 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