Recall Z-2135-2014— Enhancement Medical, LLC
Class I · Terminated
Class I FDA medical device recall by Enhancement Medical, LLC, initiated 2013-08-07, terminated 2017-09-29. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- Enhancement Medical, LLC
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-08-07
- Terminated
- 2017-09-29
- Firm location
- Wauwatosa, WI, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.