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John Bisnar
John Bisnar
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Shelhigh Medical Devices Seized by FDA

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FDA claims repeated problems with contaminatiion.

Shelhigh, a manufacturer of medical devices, is known in medical circles for producing some of the most state-of-the-art medical devices available to patients in the last ten years. However, recent problems with repeated medical device contamination at Shelhigh’s single manufacturing facility in Union, NJ has not only caused a recent FDA ‘recall’ and ‘seizure’ of inventory, but reported repeated and continued contaminations during the manufacturing process have potentially put Shelhigh medical device users at great risk.

If you have been implanted with one of Shelhigh’s medical devices read on………you may be at risk for infection and failure of your device because of contamination during what the FDA characterized as the unsanitary conditions present in Shehigh’s manufacturing process.

Who is at risk? Infections breed best in those people who are already compromised. Such as: critically ill patients; pediatric patients; and, those with other diagnosed immuno-compromising illnesses are most at risk. This is so because their bodies are generally unable to fight off the most innocuous of infections.

Shelhigh’s medical devices include pediatric heart valves and conduits, which are tube-like devices used for blood flow; surgical patches; dural patches; annuloplasty rings and arterial grafts.

If you are a confused patient, as many seem to be, please try to understand that the ‘seizure’ and ‘recall’ of Shelhigh medical devices only means that the existing devices at the company and elsewhere will not be introduced into the market until the FDA determines that the unsanitary conditions within the manufacturing plant have been remedied. And, while some types of contamination may affect the life of the medical device, it does not necessarily mean that your device will need to be removed. Seizure is meant to stop further distribution of a product until safety standards are met.

Finally, be certain to notify all of your doctors if you believe you may have a Shelhigh implant that falls within the ‘recalled’ group; follow doctor’s instructions to the letter; and, call the doctor at any sign of infection…

Need a legal consultation regarding a medical device. Contact us. All initial consultations are free and confidential.