Enhancement Medical Recalls Injectable Gel Due to Production Process Change
Enhancement Medical is recalling 17,875 units of EXP-150 Injectable Gel because a production change altered the final gel weight. The recall covers all lots distributed in the US and Canada.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
Plain-English summary
Enhancement Medical, LLC is recalling 17,875 units of the EXP-150 Injectable Gel, a 1.5cc syringe containing 20 mg/ml of hyaluronic acid. The product is labeled as an Intranasal Splint intended to minimize bleeding and edema, but it is also being used off-label as a subcutaneously injected dermal filler.
The recall was initiated because the manufacturer made a change in the production process that resulted in a change in the final gel weight. On July 8, 2014, the firm expanded the recall to include all lots of the product.
The affected product was distributed nationwide in the United States, including Puerto Rico, and internationally to Canada. Specific lot numbers involved include Z36-074, Q36-136 through Q36-140, R36-168 through R36-172, S36-189 through S36-192, S36-194, S36-202, and S36-203.
The recalled product
- 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…
- Manufacturer
- Enhancement Medical, LLC
- Category
- Medical Device — Injectable Gel
- Affected units
- 17,875
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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.
Distribution
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