Bubbles appear only when the line is pressurised — a fault conditional on how it is used (Baxter, 24,528 units)
The U.S. Food and Drug Administration classified Baxter's Duo-Vent Solution Set (product code 1C8507), an IV administration set, as Class I — its most serious category. 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. The quantity is 24,528 units, distributed within the United States only.
Recall overview (primary data)
- ClassificationClass I (most serious)
- Product typeMedical Device
- Recalling firmBaxter Healthcare Corporation
- ReasonBaxter 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.
- DistributionUS Nationwide. No OUS consignees.
- Recall initiated2026-06-30
Key points
- Recall number Z-2766-2026; FDA Class I, the most serious category; status Ongoing.
- The product is the Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, product code 1C8507 (a solution administration set).
- The reason is customer reports of air bubbles in the drip chamber and tubing when a pressure cuff is in use or the tubing is flushed fully open.
- Quantity 24,528 units, distributed U.S. nationwide with no consignees abroad. The recalling firm is located in Illinois.
- Voluntary, firm-initiated. Initiated 2026-06-30; reported 2026-08-19.
- Of the 779 device records this site holds as of 2026-09-01, 24 use conditional may-not wording and 40 name a failure outright.
1What an administration set and its drip chamber do
An IV administration set is the tubing assembly that connects an infusion bag to the patient. The drip chamber partway along it lets a clinician watch the drip rate, and it also separates liquid from air: air arriving from the bag side is meant to be caught there and kept out of the tubing beyond it.
A report of air bubbles in the drip chamber and the tubing therefore points to that air-stopping function not working as intended. Air entering a blood vessel can cause an air embolism, which is why the introduction of air into an infusion circuit is treated as serious.
2It appears when fluid is being pushed in fast
The record names two conditions: while a pressure cuff is in use, and when the tubing is flushed at the fully open position. A pressure cuff squeezes the infusion bag from outside to raise the flow rate, and it is used where fluid has to go in quickly — major bleeding, or the operating room. Flushing at full open is likewise an action for filling a line rapidly or clearing an obstruction.
In other words, the conditions under which the fault appears all coincide with situations where staff are working against the clock. A problem that does not show up during an unhurried infusion but does show up when there is no slack matters twice over: it is easy to miss, and the consequences are larger.
324,528 units, United States only
The quantity is 24,528 units, distributed U.S. nationwide with no consignees outside the country. Administration sets are single-use consumables, so hospitals hold them in quantity as routine stock. Identifying and physically quarantining affected lots therefore has to happen without stopping ordinary clinical work.
4A fault conditional on how the device is used
Of the 779 device records this site holds as of 2026-09-01, 24 use conditional wording of the may-not kind in the reason for recall, and 40 name a failure outright.
A condition means it does not happen every time. Where, as here, it appears only under a particular use — pressurising the line to infuse rapidly — an ordinary check will not reproduce it. A fault that requires the manner of use to complete it is correspondingly harder to notice in the field.
Why it matters
Administration sets are single-use consumables held in large quantities as hospital stock, so the practical question is whether affected lots can be identified and quarantined without interrupting care. Because the fault appears in the narrow setting of rapid infusion, securing substitutes is a decision that prioritizes emergency and surgical departments. The case also illustrates the value of a system that surfaces the gap between design assumptions and actual use from customer reports.
FAQ
What is the drip chamber for?
Why does it happen under pressure?
Why is air dangerous?
Sources (primary)
Source: openFDA (U.S. FDA, CC0 public domain). Data is provided as-is and must not be used for medical decisions. Verify the latest and exact details with the official FDA recall information. This site is not endorsed or certified by the U.S. FDA.
- FDA recall information (official)
- openFDA (data provider)
- Recall number: Z-2766-2026