Fresenius Kabi Issues Ivenix Infusion Pump Software Update Letter: FDA
Manufacturer is advising customers to immediately update software on affected infusion pump systems to prevent severe patient injuries.
Tag Archives: Fresenius
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FDA Warns About Failure Risks with Fresenius Ivenix Infusion Pumps
Early alert is part of an FDA pilot program intended to warn about dangerous risks associated with medical devices, before a recall is officially announced.
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Ivenix Primary Administration Infusion Pump Recalled Due to Uncontrolled Medication Flow
The manufacturer is instructing customers with recalled infusion pump systems to immediately destroy or quarantine the impacted products to prevent overdose injuries and deaths.
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Fresenius Stay-Safe Catheter Extension Set Recall Issued Due to Toxic Compound Exposure Risks
This is the latest in a series of massive catheter recalls in recent years, for a variety of defects that have endangered patients' health.
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Fresenius Gets FDA Warning Letter Over Hemodialysis Recall Problems
Fresenius must provide a response to the FDA warning letter within fifteen business days, or it may lose approval to manufacture hemodialysis machines.
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Fresenius Sanxin Single Use Syringe Recall Issued Due to Risk of Blood, Heparin Leaks
The FDA warns that the recalled syringes could cause infections, blood loss, increased blood clot risks, embolism and death.
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Fresenius Hemodialysis Machine Recall Issued Due to Toxic Compound Exposure Risks
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.
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Children Twice as Likely to Die if Treated at For-Profit Dialysis Centers, Study Warns
For-profit dialysis centers are less likely to offer potentially life-saving treatment if those services are less profitable, researchers found.
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Ivenix Infusion System Recall Issued Over Risk of Leaks, Serious Injuries and Death
Federal regulators warn Ivenix Infusion Systems leaks can cause serious injury and death.
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Risk of Toxic Exposures from Dialysis Systems Results in FDA Warning Letter to Health Care Providers
The agency indicates it is still analyzing the potential health risk of toxic exposures from the affected dialysis systems.
