Z-2135-2014 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2014
- Initiation Date
- August 7, 2013
- Termination Date
- September 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,875
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
Code Information
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.