Z-2766-2026Class I

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

Name: Z-2766-2026 Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Creator: Baxter Healthcare Corporation
Published: 2026-06-30
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-06-30 / Open, Classified

FDA source

Baxter Healthcare Corporation began a recall of Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets on 2026-06-30. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2766-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-06-30
Posted: 2026-08-11
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Product code: FPA Set, Administration, Intravascular
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.
FDA root cause: Under Investigation by firm
Action: 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
Quantity in commerce: 24528 units
Distribution: US Nationwide. No OUS consignees.
Product codes and lots: UDI/DI 00085412014319, Lot Numbers: DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2766-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2766-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-08-19	2026-08-11

Product code FPA

K243529Class IISolution Administration SetsBaxter Healthcare Corporation / cleared 2025-03-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)