FirstAlerts

FDA Closes Recall of Baxter Duo-Vent Solution Sets

The FDA has closed the Class I recall of certain Baxter solution administration sets, meaning the agency considers the recall carried out.

2 reports on this incident · first at Aug 26, 2026, 8:16 p.m. ET

By AI ReporterWritten Aug 26, 2026, 8:23 p.m. ET
Developing · checked 2h ago

This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

We last searched for new coverage of this at Aug 26, 2026, 9:39 p.m. ET — checked 2h ago.

The U.S. Food and Drug Administration has closed the recall of Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507, according to the agency's enforcement report for recall number , dated August 19, 2026. The closure means the FDA considers the recall carried out. The recall, initiated June 30, 2026, covers 24,528 units distributed nationwide. The FDA classified the recall as , its most serious category, used where there is a reasonable probability that using the product will cause serious harm or death. Affected lots are DR26C27062 (exp. 30-MAR-2028), DR26D14031 (exp. 15-Apr-2028), and DR26E13055 (exp. 14-May-2028), with UDI/DI 00085412014319. The FDA database records no other enforcement action by this firm.

Earlier reports

  1. Aug 26, 2026, 8:16 p.m. ETFirst report

    Baxter Recalls Duo-Vent Solution Sets Over Air Bubble Reports

    Baxter Healthcare Corporation is recalling its Duo-Vent Solution Set and Male Luer Lock Adapter (Product Code 1C8507) after receiving 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 recall, initiated on June 30, 2026, affects 24,528 units distributed nationwide in the U.S., with no overseas consignees, according to the FDA enforcement report (Recall Number Z-2766-2026).

    The FDA has classified the recall as Class I, its most serious category, indicating a reasonable probability that use of the product will cause serious harm or death. The affected lots are DR26C27062 (exp. 30-MAR-2028), DR26D14031 (exp. 15-Apr-2028), and DR26E13055 (exp. 14-May-2028), identified by UDI/DI 00085412014319. The recall is ongoing as of the report date of August 19, 2026.

    The product is a sterile, single-use solution administration set used to transfer liquids from a fluid container to a catheter or extension line, typically sold in bulk cartons to professional healthcare entities. The FDA database records no other enforcement actions by Baxter, though this recall history does not indicate fault in this action.

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Revision history

  1. Version 127 Aug 2026, 00:16current

    First published.

  2. Version 127 Aug 2026, 00:23current

    First published.

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