Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. Product Usage…
Enhancement Medical, LLC · 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 incl…
- Status
- Terminated
- City
- Wauwatosa
- State
- WI
- Country
- United States
- Classification
- Class I
- Product type
- Devices
- Event ID
- 68596
- Recalling firm
- Enhancement Medical, LLC
- Address 1
- 10201 Innovation Drive
- Address 2
- Suite 450
- Postal code
- 53226
- Voluntary mandated
- Voluntary: Firm initiated
- Initial firm notification
- Visit
- Distribution pattern
- Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
- Recall number
- Z-2135-2014
- Product quantity
- 17,875
- Recall initiation date
- 20130807
- Center classification date
- 20140808
- Termination date
- 20170929
- Report date
- 20140820
- 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.
- Code info
Lot numbers to follow: Z36-074, 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.