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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
Part of a larger recall action
This product is one of 3 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- HighBaxter Recalls Likorall Overhead Lifts Due to Motor Shaft Breakage Risk
FDA (Devices) · 2026-10-21
- ModerateBaxter Recalls Two VOLARA Systems Due to Potential Flow Rate Inaccuracy
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ 36-inch Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter PRO+ Mattress Recalled for UDI Labeling Error
FDA (Devices) · 2026-09-30
- ModerateBaxter Recalls PRO+ MRS Mattress Due to UDI Labeling Error
FDA (Devices) · 2026-09-30
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
Similar recalls
- SevereBaxter CLEARLINK System Non-DEHP Solution Set recalled due to leak reports
FDA (Devices) · 2022-09-21
- SevereBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- HighDuo-vent solution sets recalled across three lots because sets may leak
FDA (Devices) · 2025-10-22
- ModerateBaxter INTERLINK Y-Type Solution Set Recalled for Particulate Matter
FDA (Devices) · 2016-01-13
- HighBaxter Recalls Vented Spike Adapters Due to Potential Pouch Tears
FDA (Devices) · 2013-11-06
- HighIntravenous solution sets recalled after customer reports of tubing separation
FDA (Devices) · 2025-10-01