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.
Tag Archives: Hemodialysis
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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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Needle Dislodgement Problems Pose Risk During Dialysis Treatment: Report
An alarm system that can detect dialysis needle dislodgement problems is widely used in Europe, but currently unavailable to most Americans.
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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.
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Medtronic Palindrome and Mahurkar Catheter Recall: Defect Could Cause Serious Injury or Death
The Medtronic Palindrome and Mahurkar catheter recall warns of the risk of blood clots and severe bleeding events
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Fresenius Hemodialysis Machines May Expose Patients to Toxic Compounds, FDA Warns
The FDA is investigating the Fresenius hemodialysis machines to determine the risk to patients.
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Levaquin, Similar Antibiotics May Increase Risk of Cardiac Arrest in Hemodialysis Patients: Study
Side effects of respiratory fluoroquinolone antibiotics were already known to affect patients' heart rhythms.
