DeviceSignal · Recall classified

Baxter Healthcare Corporation

FDA classified a device recall on 2026-08-11 · Class I · Z-2766-2026

EventRecall classified
Effective2026-08-11
ClassificationClass I

On 2026-08-11 the FDA classified a device recall from Baxter Healthcare Corporation as Class I. Product: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution…. Recall Z-2766-2026. The firm initiated it on 2026-06-30. This reports the classification FDA published on that date.

Reported facts

Recall number
Z-2766-2026
Classification
Class I
Classified on
2026-08-11
Initiated on
2026-06-30
Firm
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 fully open position.
Product
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Administration Sets

Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.

Provenance

Source
fda_device_enforcement
Source record
Z-2766-2026
Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72
Source URL
https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
Observed
2026-09-08T16:22:09.483Z
Transform
fda_device_enforcement_to_recall v1
Event rule
fda_device_recall_classified v1
Event key
d124c53990e01f6f9c2695f6de966d92a7567c7c3c29106c3d9d69dae86bbb75
Signal type
device_recall.classified

Source terms that apply

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Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)