—#216068

Product

CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Backcheck Valve, 10 drops/mL, 112-inch (2.8 meters), Product Code 2C8519

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K203609
Affected lot / code info: UDI/DI 00085412048994, Lot numbers: R25A25147, R25B21086, R25C20130, R25C25055, R25C25161, and R25C29185

Why it was recalled

IV sets may leak.

Root cause (FDA determination)

Process control

Action the firm took

Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 8/29/2025 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 product. The product codes and lot numbers can be found on the individual product package and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and replacement 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, acknowledge receipt by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. 4. If you purchased this product from a distributor or wholesaler, please contact your supplier to arrange for return of the affected product. Please note that responding on the Baxter customer portal 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 medical director, purchasing director, and any other departments within your institution who use the affected product. 6. If you are a wholesaler, distributor/reseller, or OEM that distributed any affected product, please conduct a user-level recall of the affected product and check the associated box on the customer portal. For questions, please contact Baxter Healthcare Center for Service at 888-229-0001, 7:00 am and 6:00 pm Central, M-F.

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.

Timeline

Recall initiated: 2025-08-29
Posted by FDA: 2025-10-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216068. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.