Reported Aug 20, 2014 · Terminated
Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20…
Enhancement Medical, LLC
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Enhancement Medical, LLC · 10201 Innovation Drive · Wauwatosa, WI · 53226
Is this the product you have?
- Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml
- Product UsageExpression 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
- Lot codes and dates
- Lot numbers to followZ36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203. RECALL EXPANDED 7-8-2014 to include ALL LOTS
- Amount recalled
- 17,875
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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