Summary: Fresenius Kabi has recalled a specific lot of Ivenix LVP Primary Administration Sets due to a manufacturing defect that could cause uncontrolled medication flow, leading to serious health risks. The FDA has classified this recall as the most serious type.

Key Takeaways:

  • The recall affects only lot 3010538, and customers are advised to stop using, quarantine, and replace the affected product immediately.
  • The Ivenix Large Volume Pump is used in hospitals and outpatient centers to precisely control fluid delivery and requires specific single-use administration sets.

Fresenius Kabi is recalling a certain lot of the Ivenix LVP Primary Administration Sets after identifying a manufacturing defect that may cause uncontrolled medication flow.

The use of the affected product may cause serious adverse health consequences, including medication overdose and death. There have been two reported injuries, but no reports of death. The FDA has identified this recall as the most serious type, indicating that the device may cause serious injury or death if used.

Specific Lot Affected by the Recall

This recall is limited to a specific lot: 3010538. Other lots are not affected.

On August 2, 2024, Fresenius Kabi sent an Urgent Voluntary Recall letter to all affected customers, recommending the following actions:

  • Stop using and distributing the affected product immediately.
  • Check inventory and quarantine the affected product.
  • Destroy or return the affected product and request replacements.
  • Contact Fresenius Kabi Customer Service if you intend to destroy the recalled product or request replacements.

Replacement and Notification Steps

  • Replace inventory with unaffected product.
  • Ensure all potential users are aware of the notification.
  • Complete the customer reply form included with the letter by fax or email, even if there is no affected product on hand.

About the Ivenix Large Volume Pump

The Ivenix Large Volume Pump (LVP) is one of three primary components of the Ivenix Infusion System. It uses air pressure to precisely control the flow of fluids to the patient and is used in hospitals and outpatient centers to administer fluids through various routes, including IVs, arteries, the spine, or under the skin. It is intended for use with adults, pediatrics, and newborns.

The Ivenix Large Volume Pump is compatible only with specific sterile, single-use, disposable administration sets, including the Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site.