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CLEARLINK/CONTINU-FLO recallZ-2594-2025 · Baxter Healthcare Corporation · initiated Aug 8, 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

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-2594-2025
Status
Open, Classified
Initiated by the company
Aug 8, 2025
Posted by the FDA
Sep 19, 2025
Recalling firm
Baxter Healthcare Corporation
Quantity
14400 units
Product code
FPA
FDA submissions
K203609
Distribution
US Nationwide distribution.

Product description

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

Code information (models, lots, serial numbers)

UDI/DI 00085412048994, Lot Number R24I20079, Exp. 9/21/2026

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.

Sources and updates

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