Baxter Healthcare Corporation recalls Baster Continu-Flo Solution Set

Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-Flo solution sets listed below due to customer reports of tubing separation.

Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valves, Backcheck Valve. 10 drops/mL. 112" (2.8 m), Product Code REF 2C8519; intravascular administration set

Baxter issued an Urgent Medical Device Recall notice was issued its consignees on 8/8/2025 via U.S.P.S., first class mail. The notice explained the issue, potential hazard involved and requested the following: Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the affected lot number 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 between the hours of 7:00 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 OnProcess Technology 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 distribu

• FDA enforcement recordOfficial FDA database entry for Z-2594-2025
• FDA 510(k) clearance · K203609The device's official FDA premarket clearance record
• FDA device classification · FPAOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5440The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.