FDA-Device2025-01-15Class II

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

3B Medical, Inc.
Hazard

The devices were inadvertently shipped after their expiration date.

Sold states
US: Massachusetts and Arkansas OUS: None
Affected count
5010 units
Manufactured in
203 Avenue A Nw Ste 300, Winter Haven, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0828-2025

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