According to the FDA, Freesius Kabi is recalling one lot of the Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site due to a serious manufacturing defect. Continued use of the product could result in injury or death.
Freesius Kabi sent the recall letter on August 2, 2024. The recall applies to the Ivenix LVP Primary Administration Sets Dual-Inlet from Lot # 3010538 with a UDI of 20811505030058/SET-0013-25. The Ivenix LVP Primary Administration Sets are made to work in conjunction with the Ivenix Large Volume Pump, which “uses air pressure to precisely control the flow of fluids to the patient” during an infusion. Health care providers use the system to administer medications intravenously or “in arteries, in the spine, or under the skin.” The recalled Y-site port product is sold in a pack of 25.
The company issued the recall after receiving two reports of patient injury related to use of the Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site. Freesius Kabi discovered a manufacturing defect that causes the ports in the affected lot to continue administering medication despite the dosage settings selected by the health care provider. This defect can cause patients to receive dosages of medication in excess of recommended limits, which puts patients at risk for serious injury and, in extreme cases, death.
Freesius Kabi asks that health care facilities and providers stop using the specified ports from Lot # 3010538 immediately. All facilities and distributors should remove the product from stock and should notify all users of the ports of the recall. Customers can contact Customer Service at (855) 354-6387 (Option 1) to request instructions for destroying the ports, arranging replacements, or returning the product for a refund.
Along with the urgent recall letter, Freesius Kabi sent a customer reply form to all customers. The company asks that users and facilities complete and return the form at their earliest convenience.
All questions can be directed to Fresenius Kabi customer support by phone at 1-855-351-6387 or by email at ivenix_support@fresenius-kabi.com.
Patients and health care providers can report any new adverse health events related to the Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an adverse health outcome, such as medication overdose, after receiving an infusion with a faulty port system, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medical devices to health care facilities in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.