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.
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.
Manufacturer is instructing customers to stop using recalled Ivenix infusion pumps until new software is installed, to avoid serious risks that may be caused by the devices delivering reduced doses of medications and fluids.
The manufacturer is instructing customers with recalled infusion pump systems to immediately destroy or quarantine the impacted products to prevent overdose injuries and deaths.