Shelhigh Products Seized
Following documentation of serious concerns over flaws in the manufacturing of implantable medical device that may diminish devices safety and efficacy, investigators from the FDA and US Marshals seized all such devices from Shelhigh, Inc.
The original warning to the company followed an FDA inspection last fall which noted significant breaches of protocol in assuring sterile procedures. Products seized include pediatric heart conduits and valves, annuloplasty rings, dural patches, arterial grafts, and surgical patches. See the FDA for a complete list of devices manufactured by Shelhigh.
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April 17, 2007 Related topics: Product Recalls, Medical Devices & Products, Surgery