Enhancement Medical, LLC recalls Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20

Recalled August 20, 2014 · FDA recall Z-2135-2014 · Enhancement Medical

Hazard

Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product. · FDA Class I

Units

17,875

Sold at

Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.

Description

Manufacturer made a change in the production process that resulted in a change in final gel weight. RECALL EXPANDED 7/8/2014 Firm expanded their recall to include all lots of product.

Product

Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.

Manufacturer(s)

Enhancement Medical, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →