Shelhigh Medical Device Public Health Notice

FDA Executes Rare Seizure of Products

Shelhigh, Inc. of Union, New Jersey is a company that’s quite prominent in the field of manufacturing and distributing medical devices.  Specifically, Shelhigh is in the market of pediatric heart valves and conduits, which are generally used to help children who are either born with or develop serious heart complications. 

The FDA action follows several steps of intended enforcement of what it feels are/were serious violations of industry standards, and the FDA has warned Shelhigh several times, inspected their facility months prior to this action and held several meetings to discuss the specific issues that Shelhigh needed to handle if they were to continue with their manufacturing and distribution unabated. 

The Violations
The FDA generally categorized the violations at issue to be, “significant deficiencies in the company's manufacturing processes.”  This citation can be found on the FDA’s Web site at the URL http://www.fda.gov/bbs/topics/NEWS/2007/NEW01612.html.  The FDA goes on to state that the specific 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.”

These are obviously serious violations, especially considering how critical it is that these products maintain their sterile integrity and dependability.  Any problem with any of these devices can immediately cause irreversible damage in the children who receive these products, and that, along with the FDA’s apparent opinion that Shelhigh was not moving quickly enough to correct these problems, led to the seizure of these products.

The Parts in Question
The FDA states that it pulled all of the products from distribution, and the list of these specific products appears below:

• 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
• Shelhigh Injectable Pulmonic Valve System

The FDA also recommends that doctors use different products if they are already in possession of any of the items listed above.  If your child has received any of these products during a heart procedure, seek immediate medical attention.  After you’ve obtained the required medical care, contact a defective medical device attorney immediately to schedule an initial consultation. 

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