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.
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/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108906.htm).
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
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.
4. If you note a failure or problem with a Shelhigh device, please follow the reporting instructions below.
Reporting Adverse Events to FDA
Hospitals and other user facilities have an obligation under 21 CFR Part 803, to report certain device-associated death and serious injury events to FDA and/or the device manufacturer. Typically, device-associated deaths are to be reported to the manufacturer and FDA; device-associated serious injuries are to be reported to the manufacturer or to FDA if the manufacturer is unknown. We are asking you to please consider sending a copy of all reportable device-associated events to both FDA and Shelhigh, Inc.
If you suspect that a death or serious injury may have been associated with the use of a device manufactured by Shelhigh, Inc., please immediately notify the Medical Device Reporting (MDR) contact person at your facility. If a Shelhigh device was explanted because of actual or suspected infection please include details of any analysis you may have conducted. Also, let your MDR contact person know that FDA is requesting a copy of the event report. The event should be reported to FDA on the Form 3500 A.
User facilities do not have a mandatory obligation to submit malfunction events to either FDA or the device manufacturer. However, in this situation we are asking that you report such events to FDA through our MedWatch Adverse Event Reporting program, especially if you have evidence or suspicion of a malfunction involving Shelhigh devices.
You can report events to FDA in a number of ways. Access to FDA report forms 3500 and 3500A, and information on completing these forms, are available at the MedWatch internet site. Mandatory reports go on Form 3500A; completed forms must be mailed (cannot be submitted online) to FDA at 5600 Fishers Lane, Rockville, MD 20852-9787. Voluntary reports using Form 3500 can be submitted any of the following ways: (1) online from the MedWatch site, (2) entered on a downloaded form and mailed to FDA or faxed to 1-800-FDA-0178, or (3) reported by telephone to 1-800-FDA-1088.
Getting More Information
If you have questions about this Notification, please contact FDA's Division of of Small Manufacturers, International and Consumer Assistance (DSMICA) by e-mail at firstname.lastname@example.org or by phone at 1-800-638-2041 or 301-796-7100
FDA medical device Public Health Notifications are available on the Internet. You can also be notified through e-mail each time a new Public Health Notification is added to our web page. To subscribe to this service, visit http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10.
If you have any questions about when to report an adverse event, please contact the Reporting Systems Monitoring Branch, (HFZ-533) 1350 Piccard Drive, Rockville, Maryland, 20850, Phone: 240-276-3464 Fax: 240-276-3454, or by email at email@example.com.
Daniel G. Schultz, MD
Center for Devices and Radiological Health
Food and Drug Administration
* CDRH Preliminary Public Health Notifications are intended to quickly share device-related safety information with healthcare providers when the available information and our understanding of an issue are still evolving. We will revise them as new information merits and so encourage you to check this site for updates.