FDA issues recall on infusion pump parts due to risk of uncontrollable drug flow
The U.S. Food and Drug Administration (FDA) has issued a recall on behalf of Fresenius Kabi for a specific lot of the company’s Ivenix infusion pumps—specifically the administrative sets on those systems. The recall was voluntarily initiated due to a manufacturing error that could cause medication to flow at an uncontrollable rate.
Ivenix infusion systems work like many other pumps, utilizing air pressure to precisely control the flow of liquids—typically containing drugs—as they are administered to patients. These particular devices are primarily used in hospitals and outpatient clinics, where use of systems must cease immediately.
Due to the serious risk of potentially fatal overdose, the FDA has labeled this recall the most serious of its kind. There have been two reported injuries, but no deaths have been linked to the malfunctioning administrative sets on the pumps.
What is being recalled?
The recall is for one specific lot of Ivenix LVP Primary Administration Sets, of which only 25 were manufactured. The details are as follows:
- Product Name: Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site
- Unique Device Identifier (UDI): 20811505030058/SET-0013-25
- Lot Number: 3010538
Next steps
Fresenius Kabi sent a letter Aug. 2 to all impacted customers that should contain instructions on how to replace the recalled administrative set on the pumps. After immediately removing the infusion pumps from care settings and ensuring they cannot be used, customers can return affected units to the company for a replacement.
Anyone with one of the pumps with a defective administrative set should contact Fresenius Kabi Customer Service at 855-354-6387 to initiate a return. Customers must submit a reply form to receive a replacement product.
The FDA and Fresenius Kabi also ask that providers share the recall notice to ensure all potentially dangerous devices are removed from supply. The notice can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.