CLASS I ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter recalled

Baxter Healthcare is recalling Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, distributed nationwide in the US. The recall was initiated on 30 Jun 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesUDI/DI 00085412014319, Lot Numbers: DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028
Quantity recalled24528 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2766-2026
FDA event ID
99343
Recalling firm
Baxter Healthcare, Deerfield, IL
Classification
Class I
Status
Ongoing
Recall initiated
30 Jun 2026
FDA classified
11 Aug 2026
Reported
19 Aug 2026
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons
Device type
Infusion Pumps

Timeline

30 Jun 2026Recall initiated by company
11 Aug 2026Classified by FDA+42 days
19 Aug 2026Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Where it was distributed

US Nationwide. No OUS consignees.

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

UDI/DI 00085412014319, Lot Numbers: DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028

Where was it sold?

US Nationwide. No OUS consignees.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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