Baxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
Baxter Healthcare is recalling 24,528 units of Duo-Vent Solution Sets due to customer reports of air bubbles in the drip chamber and tubing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or when the tubing is flushed at the fully open position."
Plain-English summary
Baxter Healthcare Corporation is recalling 24,528 units of Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507. The affected lots are DR26C27062, DR26D14031, and DR26E13055, with expiration dates ranging from March 30, 2028, to May 14, 2028. The product was distributed nationwide in the United States.
The recall was initiated after Baxter received customer reports of air bubbles appearing in the drip chamber and tubing. These issues were observed when a pressure cuff was in use or when the tubing was flushed at the fully open position.
Healthcare facilities and consumers should stop using the affected product immediately and contact Baxter Healthcare Corporation for further instructions or a replacement.
The recalled product
- Product
- Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
- Manufacturer
- Baxter Healthcare Corporation
- Hazard
- Affected units
- 24,528
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 (7)
- UDI/DI 00085412014319
- Lot Numbers: DR26C27062
- exp. 30-MAR-2028
- DR26D14031
- exp. 15-Apr-2028
- DR26E13055
- exp. 14-May-2028
Distribution
Distributed nationwide across the United States.
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