On May 2, 2007, the FDA issued a formal written request to Shelhigh, Inc. to recall ALL of its medical devices remaining in the marketplace. I blogged in April about the April 17, 2007 raid by U.S. Marshals of Shelhigh’s Union, N.J. plant. At the FDA’s request, the Marshals seized all medical devices found at the plant because of concerns that the devices were not sterile. During the raid, the FDA asked Shelhigh to voluntarily recall all of its products, but the company declined to cooperate.
Shelhigh manufactures devices that are surgically implanted into seriously ill patients. Thus, it is critical that these devices are sterile. Non-sterile devices implanted into patients can result in serious infections, multiple organ failure, Severe Inflammatory Response Syndrome, and death. Shelhigh’s own internal records show a number of sterility test failures. FDA recommends that patients concerned about Shelhigh devices visit www.fda.gov/cdrh/satety/041907-shelhigh.html and www.fda.gov/cdrh/medicaldevicesafety/atp/o41907-shelhigh.html for more informaton.
If you or a loved one experienced an adverse reaction following implant surgery involving heart valves, blood flow conduits, surgical patches, dural patches, annuloplasty rings, or arterial grafts, please contact us.