Shelhigh Medical Device Recalls

On April 17, 2007, U.S. Food and Drug Administration (FDA) investigators and U.S. Marshals seized all implantable medical devices from Shelhigh, Inc. in 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.

Shelhigh's Alleged Device Safety Violations

All medical device companies must follow current good manufacturing practice, a set of requirements that help to ensure the safety and effectiveness of all medical products. Shelhigh's violations include:

manufacturing products in a facility with a poorly constructed and poorly maintained clean room where sterilized devices are further processed;
failing to adequately monitor critical manufacturing environments for possible microbial contamination;
failing to properly test products for sterility and fever-causing contaminants; and
failing to scientifically support product expiration dates.

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Advice for Shelhigh Patients

Physicians should consider using alternative devices. Physicians should also monitor patients with a Shelhigh implant for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information.

List of Shelhigh Medical Devices

Medical devices manufactured by Shelhigh include:

Shelhigh Pericardial Patch
Shelhigh No-React Pericardial Patch
Shelhigh No-React PneumoPledgets
Shelhigh No-React VascuPatch
Shelhigh No-React Tissue Repair Patch/UroPatch
Shelhigh Pulmonic Valve Conduit No-React Treated
Shelhigh No-React Dura Shield
Shelhigh BioRing (annuloplasty ring)
Shelhigh No-React EnCuff Patch
Shelhigh No-React Stentless Valve Conduit
Shelhigh Internal Mammary Artery
Shelhigh Gold perforated patches
Shelhigh Pre Curved Aortic Patch (Open)
Shelhigh NR2000 SemiStented aortic tricuspid valve
Shelhigh BioConduit stentless valve
Shelhigh NR900A tricuspid valve
Shelhigh MitroFast Mitral Valve Repair System
Shelhigh BioMitral tricuspid valve, and
Shelhigh Injectable Pulmonic Valve System

Legal Rights of the Injured

The law in most states provides individuals with legal claims and the right to compensation for injuries they suffer as a result of a defective product or the negligence of another. The injured person may file a lawsuit seeking compensation for his or her pain and suffering, medical expenses, lost past and future wages and punitive damages.

Contact Personal Injury Attorney | Lawyer

If you or a family member have suffered a serious injury, side effects or a loved one has died after using a Shelhigh medical device, please click here to contact an experienced personal injury attorney at the national law firm of Lieff Cabraser Heimann & Bernstein, LLP.

	Our lawyers have years of experience successfully representing clients in personal injury cases.
	There is no charge or obligation for our review of your case.
	In death and serious injury cases, we are pleased to visit you where you live, at no cost, to discuss your legal rights and answer your questions.
	We have retained product safety and medical experts nationwide to assist our clients with their claims.

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