An assembly error prompted Baxter Healthcare to issue a recall late last month of four lots of their Solution Sets with Duo-Vent Spikes. According to the FDA, continued use of the impacted solution sets could cause injury to patients undergoing infusion.
Health care providers use Baxter’s Solution Sets with Duo-Vent Spikes in conjunction with infusion pumps or vascular access devices to administer fluids to patients. The items included in the recall are the Solution Set with Duo-Vent Spike (Product code 2R8404 and lot numbers DR24C22079 and DR24H23086), the Clearlink System Solution Set with Duo-Vent Spike (Product code 2R8538 and lot number DR24C15109), and the Continu-Flo Solution Set with Duo-Vent Spike, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar (Product code UC8519 and lot number DR24B21017). The respective expiration dates for the recalled products are 3/24/2026, 8/26/2026, 3/16/2026, and 2/28/2026. Customers can find the lot numbers and product codes on the products’ shipping cartons.
Thus far, Baxter Healthcare has not communicated any reports of injury related to use of their Solution Sets with Duo-Vent Spikes. The company determined that the slide clamps on the recalled solution sets were installed backwards. The slide clamps are critical to proper functioning of the solution sets with the infusion pumps. An inverted slide clamp will prevent the flow of medication to the patient and could cause the patient’s blood to “backflow into the set and source container.” Such complications could be dangerous for particularly vulnerable people, such as premature infants, frail patients, or critically ill patients.
Baxter Healthcare notified customers of the recall on December 20th via an Urgent Medical Device Recall letter. This correspondence urged health care providers to cease use of the affected lots of their Solution Sets with Duo-Vent Spikes. Both Baxter and the FDA plan to continue their investigation of the issue to determine if corrections can be made to the existing products.
Anyone with questions or concerns about the recall can contact Baxter Healthcare at 888-229-0001 or by email at corporate_product_complaints_round_lake@baxter.com.
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