74 results

• Fresenius Kabi Issues Ivenix Infusion Pump Software Update Letter: FDA

  January 17, 2025

  Darian Hauf

  Federal health officials issued a Fresenius Kabi Ivenix Infusion Pump System early alert, after the manufacturer advised customers to immediately update the affected pump systems’ software to prevent severe patient injuries.

• FDA Warns About Failure Risks with Fresenius Ivenix Infusion Pumps

  December 12, 2024

  Martha Garcia

  An alert has been issued about problems with Fresenius Ivenix Infusion pumps, due to a risk that the devices may fail to deliver life-saving drugs to patients.

• Ivenix Primary Administration Infusion Pump Recalled Due to Uncontrolled Medication Flow

  September 17, 2024

  Darian Hauf

  Federal health officials have announced a Class I recall of certain Ivenix LVP Primary Administration Sets due to the potential for a manufacturing defect to allow too much medication to be delivered, increasing the risk of an overdose.

• Fresenius Stay-Safe Catheter Extension Set Recall Issued Due to Toxic Compound Exposure Risks

  April 26, 2024

  Martha Garcia

  More than 2 million Fresenius catheter extension sets are being recalled because they could leach toxic chemicals into patients' bodies, resulting in serious injuries or death.

• Fresenius Gets FDA Warning Letter Over Hemodialysis Recall Problems

  December 27, 2023

  Katherine McDaniel

  The FDA has sent a warning letter to Fresenius over its recalled hemodialysis machine, indicating the manufacturer knew for years that the tubing could release dangerous PCBs into patients' blood.

• Fresenius Sanxin Single Use Syringe Recall Issued Due to Risk of Blood, Heparin Leaks

  November 16, 2023

  Hannah Brown

  Nearly 12.5 million Fresenius Sanxin single-use syringes are being recalled following reports of blood and heparin leaks, which could result in infections, blood loss, embolism and death.

• Fresenius Hemodialysis Machine Recall Issued Due to Toxic Compound Exposure Risks

  October 25, 2023

  Katherine McDaniel

  More than 200 Fresenius hemodialysis machines may put patients at risk of serious injury or death because they can expose them toxic compounds which leach from the devices' silicone tubing.

• Children Twice as Likely to Die if Treated at For-Profit Dialysis Centers, Study Warns

  September 11, 2023

  Martha Garcia

  A new study finds children are twice as likely to die if treated at for-profit dialysis centers than at nonprofit facilities.

• Ivenix Infusion System Recall Issued Over Risk of Leaks, Serious Injuries and Death

  April 20, 2023

  Irvin Jackson

  The FDA has announced a recall of more than 1,500 Ivenix pediatric infusion pumps due to a risk of leaks which could cause the devices to fail to provide life-saving treatments to children.

• Risk of Toxic Exposures from Dialysis Systems Results in FDA Warning Letter to Health Care Providers

  March 8, 2023

  Martha Garcia

  The FDA is expanding the warning about the risk of toxic exposures from Fresenius hemodialysis machines to include other manufacturer's devices and peritoneal dialysis systems.