| Subject: | FDA Seizes All Medical Products From N.J. Device Manufacturer for Significant Manufacturing Violations |
| Category: | Food and Drug Administration (FDA)
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| Published: | Tue, 17 Apr 2007 - 05:00 pm |
| The FDA has issued an announcement that it has seized all implantable medical devices from Shelhigh, Inc. located in Union, N.J., after finding significant deficiencies in the company's manufacturing processes. According to the FDA, the deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.
The products made by Shelhigh, Inc., include pediatric heart valves and conduits, surgical patches, dural patches, annuloplasty rings and arterial grafts.... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
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