| Subject: | Class I Recall of All EnDura No-React Dural Substitute (EnDura) Products |
| Category: | Food and Drug Administration (FDA)
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| Published: | Thu, 31 May 2007 - 11:00 am |
| Integra LifeSciences (Integra) has informed healthcare professionals and patients of a recall of all EnDura No-React Dural Substitute (EnDura) products. These products are manufactured by Shelhigh, Inc. and distributed by Integra. The recall is pursuant to an FDA Public Health Notification regarding products manufactured by Shelhigh, citing sterility and other manufacturing concerns and the FDA's request that Shelhigh recall all of its medical devices remaining in the marketplace. For... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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