Events

Safety Alert for Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Fresenius Medical Care North America.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-06-28
  • Event Date Posted
    2012-06-28
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120628a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: fresenius naturalyte liquid acid concentrate and naturalyte granuflo (powder) acid concentrate the united states food and drug administrations (fda) has issued a class i recall concerning naturalyte liquid acid concentrate and naturalyte granuflo (powder) acid concentrate distributed by fresenius medical care north america. please refer to the fda website for the affected serial numbers. the manufacturer is cautioning clinicians to be aware of the concentration of acetate or sodium diacetate (acetic acid plus acetate) contained in the products as mentioned above. inappropriate prescription of these products can lead to a high serum bicarbonate level in patients undergoing hemodialysis. this may contribute to metabolic alkalosis, which is a significant risk factor associated with low blood pressure, hypokalemia, hypoxemia, hypercapnia and cardiac arrhythmia, which, if not appropriately treated, may culminate in cardiopulmonary arrest. this product may cause serious adverse health consequences, including death. the fda recommended that health care providers should review the dialysate acid concentrate labeling for the specific concentrate that they prescribe to determine the components that can contribute to the patient's overall bicarbonate levels. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ ucm305630.Htm and http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm309990.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 28 june 2012.

Device

Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Fresenius Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate
  • Manufacturer
    Fresenius Medical Care North America

Manufacturer

Fresenius Medical Care North America