Summary: Baxter is recalling certain Solution Sets with Duo-Vent Spikes due to inverted slide clamps, potentially causing medication delivery failure or blood backflow. Affected stock should be pulled from circulation, and healthcare providers should follow the FDA for updates. No injuries have been reported, but high-risk patients could face serious complications.

Key Takeaways:

  • Inverted slide clamps can prevent proper medication delivery and cause blood backflow, posing serious risks for high-risk patient populations.
  • Healthcare providers must immediately isolate affected product lots and consult FDA updates to mitigate potential harm and ensure patient safety.

Baxter Healthcare Corporation has issued a letter to affected health care providers recommending certain lots of Solution Sets with Duo-Vent Spikes be removed from use related to a potentially high-risk device issue. Baxter has not reported any injuries associated with this issue.

Urgent Medical Device Recall

On December 20, 2024, Baxter sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:

  • Immediately check your stock for the affected product and do not use it. The product code and lot number can be found on the individual product and shipping carton.
  • Check the FDA’s recall page for updates. The FDA is currently collecting information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.

RELATED: Baxter Recalls Volara System Parts For Disconnection Issues

Incorrectly Assembled Slide Clamps

Baxter reports that some Solution Sets with Duo-Vent Spikes were incorrectly assembled with inverted slide clamps. If a solution set with an inverted slide clamp is loaded on an infusion pump, the medication may not be delivered and the patient’s blood may backflow into the set and source container. Critical adverse health consequences may occur if the patient does not receive life-sustaining medication or if a significant amount of blood is removed from the patient, especially for high-risk populations, such as neonates or critically ill patients.

Device and Slide Clamp Function

These solution sets are used to administer fluids from a container to patients through a vascular access device, such as an infusion pump. The slide clamp is a feature of these solution sets designed to shut off fluid flow and interact with the infusion pump to load the set into the pump correctly.