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:
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).