Events

Rappel de NaturaLyte Liquid Acid

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
    79236
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1010-2018
  • 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=161727
  • 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 label specifies the potassium concentration is 2.0 meq/l. some of the product in the affected lot was found to have a potassium concentration of 2.25 meq/l.
  • Action
    The firm, Fresenius Medical Care, sent an "URGENT - MEDICAL DEVICE RECALL" letter dated 10/4/2017 to its Consignees. The letter described the product, problem and actions to be taken. The Consignees are instructed to: " Immediately examine your stock to determine whether you have any Naturalyte¿ Liquid Acid Concentrate from the lot listed. " If any product 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. " Promptly fill out and return the attached Reply Form via fax to: 781-699-9796 ATTN: Quality Department or SCAN and email to: NOTIFYRA@fmc-na.com.' and "Route the letter to others in your organization that may have any of the affected product that is subject to this recall. Please note that the Naturalyte¿ Liquid Acid Concentrate matching the Lot Number listed in the notification is the only lot subject to this recall. If you have any additional medical concerns or questions, please contact Medical Information and Communication: 855-616-2309 or Website: www.fresenius-medinfo.com.

Device

NaturaLyte Liquid Acid
  • Modèle / numéro de série
    Lot # 17KTAC076; UDI-00840861101696
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to states of: CA, FL, KS, LA, and TX.
  • Description du dispositif
    NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L, Model # 08-2251-0 || 3.43 liter bottle || 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.
  • 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