Enhancement Medical Recalls Intranasal Splint Due to Concentration Concerns
Enhancement Medical is recalling its Expression Intranasal Splint due to concerns the affected lots don’t contain the correct concentration of hyaluronic acid — a problem that could result in patient injury, according to a recall notice posted to the FDA’s website on Aug. 14.
The Wauwatosa, Wisc., devicemaker first recalled lots of the product in August 2013. The current Class I recall includes all lots since Aug. 15, 2012, the first date of manufacture, as the company cannot confirm that the final concentration hyaluronic acid meets established specifications.
Customers in the earlier recall were provided new product. Those products are included in the current recall, the company says.
The recall notice cites multiple complaints of swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching and hard nodules among patients who received subcutaneous injections of hyaluronic acid using Expression splints. The adverse events were related to hyperconcentrations of the substance.
Healthcare providers are advised to discontinue use of Expression Intranasal Splints and return unused product.
The affected lots — totaling 17,875 devices — were distributed through June 27.
View the recall notice at www.fdanews.com/ext/resources/files/08/08-18-14-ExpressionRecall.pdf. — Kellen Owings
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