Medical Device Safety and Recalls: Enhancement Medical, Expression – Hyaluronic Acid Concentration

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Enhancement Medical, _expression_ – Hyaluronic Acid Concentration

A recall has been issued by Enhancement Medical LLC for _expression_, which is listed with the FDA as a Class I intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. Intranasal splints are placed in the nasal cavity after surgery or trauma and are usually constructed from plastic, silicone, or absorbent material.  Enhancement Medical is conducting this recall because the firm cannot ensure that _expression_ contains the correct concentration of hyaluronic acid. Incorrect concentration of hyaluronic acid may result in injury.  For more information, please see: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm409994.htm

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