Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Summary
The FDA issued a Class I for Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; So by Baxter Healthcare Corporation. Reason: 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 ful.
Details
Source
Device Recall
External ID
Z-2766-2026
Action Date
2026-08-19
Status
Ongoing
Category
device
Product Description
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets
Lot/Code Info: UDI/DI 00085412014319, Lot Numbers: DR26C27062, exp. 30-MAR-2028; DR26D14031, exp. 15-Apr-2028; DR26E13055, exp. 14-May-2028
Quantity Affected: 24528 units
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.
Distribution
US Nationwide. No OUS consignees.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-30
Company
Deerfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 160 device recalls issued in the same week, part of 376 device-related FDA actions this month.
Baxter Healthcare Corporation has 311 FDA actions in our database, including 288 recalls and 23 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 311 FDA actions in our database, including 288 recalls and 23 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2766-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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