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CLEARLINK/CONTINU-FLO recallZ-0192-2026 · Baxter Healthcare Corporation · initiated Aug 29, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

IV sets may leak.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-0192-2026
Status
Open, Classified
Initiated by the company
Aug 29, 2025
Posted by the FDA
Oct 16, 2025
Recalling firm
Baxter Healthcare Corporation
Quantity
473040
Product code
FMG
FDA submissions
K203609
Distribution
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.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 00085412048994, Lot numbers: R25A25147, R25B21086, R25C20130, R25C25055, R25C25161, and R25C29185

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

18 devices cleared under K203609 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 97604).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page