Tuesday, April 17, 2007

Shelhigh Company's Products Pulled

The FDA has seized all implantable medical devices, including pediatric heart valves, vascular conduits, and dural patches made by Shelhigh, Inc of Union, NJ due to concerns over sterility issues.
U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals today seized all implantable medical devices from Shelhigh, Inc., Union, N.J., after finding significant deficiencies in the company's manufacturing processes. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility.

The products include pediatric heart valves and conduits (tube-like devices for blood flow), surgical patches, dural patches (to aid in tissue recovery after neurosurgery), annuloplasty rings (to help repair heart valves) and arterial grafts. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.
See the entire FDA alert here. So much for their No-React® Tissue Detoxification process.

Maybe this explains these failures with their valves.


No comments: