• Popular
    • Medicine
    • Radiology
    • Cardiology
    • Surgery
    • Nanomedicine
    • Military Medicine
    • Rehab
  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS
  • Submit PR
  • Log in
Medgadget
Medgadget
  • Popular
    • Medicine
      iLet Bionic Pancreas Cleared by FDA

      iLet Bionic Pancreas Cleared by FDA

      Urine Test for Parkinson’s Disease

      Urine Test for Parkinson’s Disease

      Investigating Bacterial Motion for New Treatment Strategies

      Investigating Bacterial Motion for New Treatment Strategies

      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

    • Radiology
      Wearable Ultrasound for Deep Tissue Monitoring

      Wearable Ultrasound for Deep Tissue Monitoring

      Implanted Ultrasound Lets Chemo Access Brain

      Implanted Ultrasound Lets Chemo Access Brain

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Wearable Ultrasound Measures Tissue Stiffness Under Skin

      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

    • Cardiology
      Wearable Ultrasound for Deep Tissue Monitoring

      Wearable Ultrasound for Deep Tissue Monitoring

      Pencil-on-Paper Wearable Sensor

      Pencil-on-Paper Wearable Sensor

      Cell Culture Chamber Mimics Mechanical States of Disease

      Cell Culture Chamber Mimics Mechanical States of Disease

      Chest Wearable Provides Key Heart Measurements

      Chest Wearable Provides Key Heart Measurements

    • Surgery
      Device Moves Esophagus for Cardiac Ablation Procedure

      Device Moves Esophagus for Cardiac Ablation Procedure

      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

      Smart Sutures Sense Inflammation, Deliver Drugs, Cells

      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

      Soft Robotic Electrode Enables Minimally Invasive Placement

      Soft Robotic Electrode Enables Minimally Invasive Placement

    • Nanomedicine
      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Bottlebrush Nanoparticles Deliver Immunostimulatory Drugs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Deliver mRNA Therapy to the Lungs

      Nanoparticles Get Lymphatic Vessels Pumping

      Nanoparticles Get Lymphatic Vessels Pumping

      Bottlebrush Particle for Synergistic Drug Combinations

      Bottlebrush Particle for Synergistic Drug Combinations

    • Military Medicine
      Wearable Can Take Multiple Sweat Samples

      Wearable Can Take Multiple Sweat Samples

      Wound Dressing Detects Infection, Changes Color

      Wound Dressing Detects Infection, Changes Color

      Device Measures Hemoglobin More Accurately in Dark Skin

      Device Measures Hemoglobin More Accurately in Dark Skin

      Fingertip Sensor Measures Lithium Levels in Sweat

      Fingertip Sensor Measures Lithium Levels in Sweat

    • Rehab
      Temperature Feedback for Prosthetic Limbs

      Temperature Feedback for Prosthetic Limbs

      Brain Decoder Spells Out Thoughts

      Brain Decoder Spells Out Thoughts

      Knitted Glove Massages the Hand to Treat Edema

      Knitted Glove Massages the Hand to Treat Edema

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

      Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

  • Categories
    • Exclusive
    • A-D
      • Anesthesiology
      • Art
      • Cardiac Surgery
      • Cardiology
      • Critical Care
      • Dentistry
      • Dermatology
      • Diagnostics
    • E-I
      • Emergency Medicine
      • ENT
      • Genetics
      • Geriatrics
      • GI
      • Informatics
    • M-N
      • Medicine
      • Military Medicine
      • Nanomedicine
      • Net News
      • Neurology
      • Neurosurgery
      • Nuclear Medicine
    • O-P
      • Ob/Gyn
      • Oncology
      • Ophthalmology
      • Orthopedic Surgery
      • Pathology
      • Pediatrics
      • Plastic Surgery
      • Psychiatry
      • Public Health
    • R-V
      • Radiation Oncology
      • Radiology
      • Rehab
      • Reproductive Medicine
      • Space Medicine
      • Sports Medicine
      • Surgery
      • Thoracic Surgery
      • Urology
      • Vascular Surgery
  • SUBSCRIBE
  • Submit PR
  • About
  • Log in
  • Submit PR
  • Follow
    • Facebook
    • Twitter
    • Linkedin
    • Youtube
    • Instagram
    • RSS

FDA Flexes Muscles Against Shelhigh

June 1st, 2007 Nicholas Genes News

bioconduitcircle.jpgWe’ve heard of the FDA revoking approval, or issuing recalls. But we didn’t know they could seize products and block shipments — perhaps because it’s rare that a company lets things get that far.
Shelhigh is one such company. Makers of a heart valve fixative process for cardiothoracic surgery, they’ve been manufacturing with substandard practices for years, causing accelerated aging in their contaminated surgical implants, FDA alleges. After countless warnings, the FDA got tough:

A seizure is an enforcement action taken as a last resort to remove a dangerous product from commerce. The FDA initiates the action by filing a complaint with the District Court where the product is located, and a US marshal is then directed by the court to take possession of the goods until the matter is resolved. The complaint against Shelhigh was filed on April 16, 2007.
The US Marshal did not physically remove the devices from the plant but rather “seized them in place,” meaning Shelhigh cannot remove, attempt to remove or in any way interfere with the products without the prior written permission from the US Marshal. The firm’s products have also been embargoed by the state of New Jersey.
In fact, the story here is not that the FDA can recruit US Marshals and can function like the DEA when it needs to — the real story is that they waited five years between their first warning and their second, and sent a half-dozen increasingly shrill warnings over 18 months before finally acting in May:
It’s difficult to understand how Shelhigh believes it has a legal leg to stand on in light of the FDA’s last 7 years of warnings, threats and promises. Investigators documented deficiencies in the firm’s Union City facility in 2000 and 2005, and those inspections resulted in warning letters to Shelhigh in April 2000 and December 2005.
A December 14, 2005 warning letter spelled out what Shelhigh was facing. “Your failure to comply with any post-approval-requirement, the FDA explained, constitutes a ground for withdrawal of the Human Device Exemption and commercial distribution of a device that is not in compliance with these conditions is a violation of the Federal Food, Drug, and Cosmetic Act.”
…As for its part, according to Mr Gaudio, the FDA would not comment on why it waited 5 years between warning letters and then nearly a year-and-a-half between the December 2005 letter and the seizure, or why it then waited 2 more weeks after the seizure to send Shelhigh a formal request for a product recall.

More from the FDA…
Shelhigh’s perspective…

Nicholas Genes

Nicholas Genes, MD, PhD, has been with Medgadget since almost the beginning. He's now Assistant Professor of Emergency Medicine at Mount Sinai, where in addition to patient care and teaching responsibilities, he studies EHR usability and physician uses of social media. Dr. Genes serves on the editorial boards of Emergency Physicians Monthly and Emergency Medicine Practice. More about Nick: http://nickgenes.com

Sponsored

Packaging Compliance Labs (PCL) Celebrates Site Expansion in Grand Rapids, MI

Novel Approach to Assessing Lung Function Enables Improved Detection, Diagnosis and Treatment Decisions in Subject Exposed to Military Burn Pits

U.S. Patent Office Grants Additional Patent Protection For  Exoskeleton Focal-Force Angioplasty Platform

U.S. Patent Office Grants Additional Patent Protection For Exoskeleton Focal-Force Angioplasty Platform

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

Reliefband® State of Nausea Study Reveals More Than Three-Quarters of Americans Are Prevented from Enjoying Life As a Result of Regular Nausea

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

New AI-Powered Voice Controls Streamline Ultrasound Imaging with All Clarius Handheld Systems

interviews & reviews
Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

Automated Computer Assistant for Kidney Transplant Rejection Diagnostics: Interview with Study Authors

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

RF Technology for Health Monitoring: Michael Leabman, CTO of Movano Health

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

AI’s role in Healthcare: Exclusive Interview with Catherine Estrampes, President & CEO at GE Healthcare

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Levels Is Making Metabolism and Blood Glucose Tracking Accessible To Everyone

Imagene Profiles Cancer Biomarkers in Real Time

Imagene Profiles Cancer Biomarkers in Real Time

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

Empowering Stroke Survivors: Interview with Kirsten Carroll, CEO at Kandu Health

  • Subscribe
  • Contact us
  • Submit
  • About
  • Back to top
Medgadget

Medical technologies transform the world! Join us and see the progress in real time. At Medgadget, we report the latest technology news, interview leaders in the field, and file dispatches from medical events around the world since 2004.

  • About
  • Editorial policies
  • Contact
  • Terms of Service
  • Privacy
  • Submit press release
  • Advertise
© Medgadget, Inc. All rights reserved. | The Medical Revolution Will Be Blogged.
Please support this website by adding us to your whitelist in your ad blocker. Ads are what helps us bring you premium content! Thank you!
  • Facebook
  • Twitter
  • LinkedIn
  • Reddit
  • Email