Class 1 Device Recall Baxter DuoVent

• Date Initiated by Firm: June 30, 2026
• Date Posted: August 11, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2766-2026
• Recall Event ID: 99343
• 510(K)Number: K243529
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
• Code Information: UDI/DI 00085412014319, Lot Numbers: DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028
• FEI Number: 1417572
• Recalling Firm/ Manufacturer: Baxter Healthcare Corporation; 1 Baxter Pkwy; Deerfield IL 60015-4625
• For Additional Information Contact: Center for One Baxter; 800-422-9837
• Manufacturer Reason for Recall: Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position.
• FDA Determined Cause: Under Investigation by firm
• Action: Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/30/2026 via USPS, first class mail. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the affected lot numbers of the product. The product code and lot number can be found on the individual product package and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and replacement product at 888-229-0001 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please contact them to arrange for return of the affected product. Please note that responding to Baxter is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to the director of nursing, director of pharmacy, director of purchasing, facility risk manager, and any other departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on
• Quantity in Commerce: 24528 units
• Distribution: US Nationwide. No OUS consignees.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FPA