The Recall Desk
HighFDA (Devices)·Z-1009-2025·Announced 2025-01-29

Baxter Solution Set with Duo-Vent Spike Recalled for Inverted Clamps

Baxter Healthcare is recalling specific lots of its Solution Set with Duo-Vent Spike due to inverted side clamps that may render the tubing unusable. The affected product was distributed nationwide.

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: This is a risk-of-harm medical device where the potential defect (inverted clamps) could prevent proper use, but no injuries or hospitalizations have been reported. Per the rubric, risk-of-harm products without reported injury are classified as High (Score 3).

Plain-English summary

Baxter Healthcare Corporation is recalling specific lots of the Solution Set with Duo-Vent Spike (REF 2R8404) due to potential inverted side clamps. The defect may cause the tubing to become unusable, affecting the safe delivery of intravenous solutions.

The recall affects two specific lot numbers: DR24C22079 (expiring 3/24/2026) and DR24H23086 (expiring 8/26/2026), identified by UDI/DI 00085412676630. The recalled product was distributed nationwide to healthcare facilities in Minnesota, Missouri, Virginia, Texas, California, Massachusetts, Florida, and South Carolina.

Affected healthcare facilities should immediately stop using solution sets from these lots. Facilities should check their inventory against the specified lot numbers and contact Baxter Healthcare Corporation for replacement product or instructions. Medical professionals and patients should report any incidents involving these products to the FDA MedWatch program.

The recalled product

Product
Baxter Solution Set with Duo-Vent Spike, REF 2R8404
Manufacturer
Baxter Healthcare Corporation
Category
Medical Device — Intravenous / Solution Delivery System
Hazard
  • device-malfunction
  • component-defect

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 00085412676630
  • Lot Numbers: DR24C22079 (exp.3/247/2026)
  • DR24H23086 (exp. 8/26/2026)

Distribution

Distributed nationwide across the United States.

Related recalls

Same category