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Issued : April 18, 2007 ...

Posted Nov 10 2008 4:25pm

Issued : April 18, 2007

Dear Healthcare Practitioner:

This is to notify you that all medical devices manufactured by Shelhigh, Inc. of Union, N.J. were manufactured under conditions that may have contaminated the devices and may result in devices that fail to function for the expected life of the products. We are also recommending actions that could help minimize risks to patients.
Background

FDA’s inspections of Shelhigh, Inc. revealed significant manufacturing problems that included improper sterilization and extension of expiration dates for the firm’s medical devices. The FDA has seized all the medical devices at the Union, N.J. manufacturing plant ( http://www.fda.gov/bbs/topics/NEWS/2007/NEW01612.html).

To identify a Shelhigh device, we recommend that you first check for the manufacturer’s name and address (Shelhigh, Inc., currently located at 650 Liberty Avenue, Union, New Jersey 07083; and, previously located at 67-71 East Willow Street, Milburn, NJ 07041), which we believe are consistently displayed on the device packaging. Below are some brand names known by FDA of medical devices manufactured by Shelhigh, Inc., including those that have not been cleared/approved by FDA:

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

Recommendations

1. Consider using alternative devices.

2. We recommend that you assess the overall health status of each patient implanted with a Shelhigh, Inc. device, and provide the testing, monitoring and care that is appropriate considering each patient’s individual case. The following information will help with your assessment:

* Shelhigh, Inc. received FDA’s clearance to market medical devices beginning in 1997.
* We are aware of published reports of premature (accelerated) failure associated with some Shelhigh devices.
* A Shelhigh device could potentially be contaminated with bacteria, fungi, and endotoxin.

3. You may wish to provide to your patients the FDA’s Preliminary Advice For Patients (http://www.fda.gov/cdrh/medicaldevicesafety/atp/041807-shelhigh.html).

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