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DUO-VENT recallZ-2766-2026 · Baxter Healthcare Corporation · initiated Jun 30, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Under Investigation by firm

What the company is doing

Baxter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/30/2026 via USPS, first class mail. The notice explained the issue, hazard involved, and requested the following: "Actions to be Taken by Customers 1. Immediately locate, isolate, and cease all use of the affected lot numbers of the product. The product code and lot number can be found on the individual product package and shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and replacement product at 888-229-0001 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number, and quantity of product to be returned ready when calling. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from Accenture LLP on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please contact them to arrange for return of the affected product. Please note that responding to Baxter is not applicable. If a response is requested by your distributor or wholesaler, please respond to them according to their instructions. 5. Please forward a copy of this communication to the director of nursing, director of pharmacy, director of purchasing, facility risk manager, and any other departments within your institution who use the affected product. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a user-level recall of the affected product that you distributed to customers and check the associated box on

Recall details

Recall number
Z-2766-2026
Status
Open, Classified
Initiated by the company
Jun 30, 2026
Posted by the FDA
Aug 11, 2026
Recalling firm
Baxter Healthcare Corporation
Quantity
24528 units
Product code
FPA
FDA submissions
K243529
Distribution
US Nationwide. No OUS consignees.

Product description

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

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

3 devices cleared under K243529 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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