Serious Manufacturing Problems
An inspection at Shelhigh, Inc. in
Union, NJ revealed serious manufacturing concerns to
the FDA. On April 17, 2007, the US Marshals
office seized all implantable medical devices due to
improper sterilization techniques used by Shelhigh,
Inc., as well as extension of expiration dates for
their medical devices.
Shelhigh, Inc.
Brand Medical Devices:
-
 Endura No-React Dural Substitute
- 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
These products are "pediatric heart
valves and conduits (tube-like devices for
blood flow), surgical patches, dural patches
(to aid in tissue recovery after neurosurgery),
annuloplasty rings (to help repair heart
valves) and arterial grafts. The
tissue-based devices are used in many
surgical settings, including open heart
surgery in adults, children and infants, and
to repair soft tissue during neurosurgery
and abdominal, pelvic and thoracic surgery"
(FDA Initial Press Release).
If you or a loved one was implanted with a Shelhigh implant, contact
the
Law Offices of Handler, Henning & Rosenberg, LLP at 1-800-422-2224 to discuss your case.
FDA Recommendations
-
It is important
to access the overall health status of each case and
it is recommended to try using alternative devices
for your medical needs. The FDA has preliminary advice for patients.
If you do notice any malfunctions or suspect that a
death or serious injury was associated with your Shelhigh
medical device, report it to the FDA.
Contact Handler, Henning & Rosenberg, LLP
at 1-800-422-2224 for a FREE Consultation and more
information regarding Shelhigh, Inc. medical
devices.
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