FDA Asks Shelhigh to Recall All its Products;
cites sterility issues with
implants
The Food and Drug Administration (FDA) has requested that medical device
maker Shelhigh Inc. recall all its products after inspections of its New Jersey
manufacturing plant raised concerns about their sterility.
The Agency
said the seizure was based on dangerous conditions inspectors found at the plant
late. Reportedly, the FDA said Shelhigh's devices are made in a poorly
constructed and maintained in an area that was not properly monitored for
possible contamination.
The FDA also said Shelhigh has failed to properly
check its medical devices for sterility and to verify information so that it
expiration dates are valid.
Many of the devices at issue are derived from
animal tissue, according to the FDA. It says those seized by the government
include pediatric heart valves, arterial grafts and patches that help tissue
heal following neurosurgery.
The Shelhigh products are used for various
operations, including open-heart surgery for adults, children and infants.
Others help repair soft tissue after abdominal, pelvic and thoracic
surgeries.
The agency has recommended that doctors and hospitals
immediately begin using products from alternative manufacturers.
If you
were implanted with one of these devices and experienced an injury, our legal
team may be able to assist you. Please complete the form below for a free legal
review of your potential case. A representative of our firm will be in touch as
soon as possible.
see also:
Shelhigh Implant
Shelhigh Stops Manufacture of Implant Due to Sterility ProblemsShelhigh implant at risk due to unsafe plant production--Lawsuit Info
FDA on Shelhigh
FDA: Possible Contamination and Malfunction of Shelhigh Inc. DevicesFDA Notifies Public about Possible Contamination of Shelhigh Implants
Shelhigh Inc.
FDA Seizes all Medical Products From Shelhigh, Inc. Due to ViolationsFDA Raid After Repeated Violations from Shelhigh Medical Devices in NJ
