Medical device recalls Moderate risk

3B Medical, Inc. recalls Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number…

Recall date
November 27, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0828-2025
FDA classification
Class II
Brand / firm
3B Medical, Inc.
Sold / distributed
US: Massachusetts and Arkansas OUS: None

Why it was recalled

The devices were inadvertently shipped after their expiration date.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: 3B Medical, Inc. Product Name: Ultrasoft Oxygen Cannula, 12 Foot Model / Catalog Number: O2U2012 Lot Number: 20170403 Product Description: Nasal Cannulas for use with Oxygen Concentrators

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