The manufacturer is instructing customers with recalled infusion pump systems to immediately destroy or quarantine the impacted products to prevent overdose injuries and deaths.
This is the latest in a series of massive catheter recalls in recent years, for a variety of defects that have endangered patients' health.
Fresenius must provide a response to the FDA warning letter within fifteen business days, or it may lose approval to manufacture hemodialysis machines.
The FDA warns that the recalled syringes could cause infections, blood loss, increased blood clot risks, embolism and death.
FDA officials warn certain recalled Fresenius hemodialysis machines can leak toxic compounds into the bloodstream for up to a month after the devices are first put into service, posing serious and deadly risks to patients.
For-profit dialysis centers are less likely to offer potentially life-saving treatment if those services are less profitable, researchers found.
Federal regulators warn Ivenix Infusion Systems leaks can cause serious injury and death.
The agency indicates it is still analyzing the potential health risk of toxic exposures from the affected dialysis systems.
The FDA is investigating the Fresenius hemodialysis machines to determine the risk to patients.
