The Recall Desk
HighFDA (Devices)·Z-2594-2025·Announced 2025-10-01

Baxter Continu-Flo Solution Sets recalled due to tubing separation risk

Baxter Healthcare recalls one lot of Continu-Flo intravascular administration sets nationwide due to customer reports of tubing separation. Affected users should stop using the product and contact Baxter or their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with customer reports of tubing separation on a critical medical device. No illnesses, injuries, or hospitalizations reported; the hazard represents risk of harm to patients using the product.

Plain-English summary

Baxter Healthcare Corporation is recalling lot R24I20079 of its Continu-Flo Solution Sets, intravascular administration sets used to deliver medications and fluids intravenously. The recall affects 14,400 units with nationwide U.S. distribution.

The recall was initiated due to customer reports of tubing separation. A separated tube could interrupt medication delivery.

Healthcare facilities and patients using this lot should discontinue use and contact Baxter Healthcare Corporation or their healthcare provider for replacement products. The affected lot is identified by UDI/DI 00085412048994, Lot Number R24I20079, with an expiration date of 9/21/2026.

The recalled product

Product
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
Manufacturer
Baxter Healthcare Corporation
Hazard
  • tubing-separation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.