FDA-Device2014-08-20Class I
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.
Enhancement Medical, LLC
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.
Sold states
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
Affected count
17,875
Manufactured in
10201 Innovation Drive, Suite 450, Wauwatosa, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2135-2014Don't want to check this manually?
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