Tuesday, 12 October 2010

Fresenius gets another warning

America's Food and Drug Administration (FDA) has issued a warning to the well-known provider of dialysis care and treatment Fresenius about problems with two of its products - Liberty Cycler sets and Naturalyte Acid Concentrate products. The warning is over a claimed failure to deal with products already in the hands of dialysis patients. Apparently the units can leak and although the company is said to have identified the problem and sorted it, units out in the field, so to speak are not having the problem resolved.

If you regularly browse medical news sites, you may have seen this reported in the last few days.

The full warning notice can be viewed at the FDA website. It lists five points that they want corrected within 15 working days.

This is not the first warning that the FDA has issued to Fresenius - there were complaints about their Phoslo gelcaps product three times in the last 18 months.