Serious riskFDA DeviceClass I

Baxter Duo-Vent IV solution sets recalled over air bubble risk

Baxter Healthcare is recalling certain Duo-Vent solution sets (product code 1C8507) because air bubbles can form in the drip chamber and tubing. Customers reported this happening when a pressure cuff was in use or when the tubing was flushed with the clamp fully open. About 24,528 units were distributed nationwide, and no injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Baxter recalls

What to do

  1. Check the product code (1C8507) and lot numbers (DR26C27062, DR26D14031, DR26E13055) on your supplies.
  2. If you have any affected lots, stop using them and contact Baxter Healthcare for next steps, since no remedy has been specified.
  3. If you are a patient receiving IV therapy with these sets, talk to your healthcare provider about alternatives.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Sold in
Nationwide
Made for
All ages (under 100 years)

Details

Units affected
24528 units
Illnesses reported
None reported
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Classification
Class I
Recall number
Z-2766-2026

In the FDA's words

Description
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets 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. UDI/DI 00085412014319, Lot Numbers: DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028 Distribution: US Nationwide. No OUS consignees. Affected quantity: 24528 units
Hazard
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.

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