Posts Tagged ‘medical devices’
PSM Releases Report on Black Market IUDs at U.S. Clinics
Between 2009 and 2014, 35 doctors in 7 states were prosecuted for exposing women to non-FDA approved IUDs. Doctors have been accused of purchasing IUDs from “Canadian” fake online pharmacies and importing untested IUDs from Mexico, then billing Medicare for the cost of genuine, FDA-approved IUDs. Over the same time period, authorities estimated that over 450 women were implanted with misbranded, black-market IUDs.
[...]Fake Diabetes Test Strips Found in India
Life-threatening counterfeit diabetes test strips were discovered in India, five years after similar fakes were discovered in the U.S. Officials believe the fakes were manufactured in China and packaged with false labeling in India for intranational distribution. Johnson & Johnson spokesman David Detmers told the Wall Street Journal that they believe the fake strips were…
[...]Pine Bluff AR Doctor Found Guilty of Health Care Fraud in Fake IUD Case
Osteopath Kelly Dean Shrum was found guilty by a jury of one count of misdemeanor Misbranding in violation of the Food, Drug, & Cosmetic Act and one count of Health Care Fraud. He was originally indicted on one count each of misbranding and health care fraud and three counts of money laundering for using imported…
[...]FDA: Don’t Use Unapproved IUDs
The U.S. Food and Drug Administration (FDA) recently warned women not to use unapproved intrauterine devices (IUDs), a form of birth control, in part because they can potentially be counterfeited. The FDA reminded health professionals in a July 22 letter that unapproved IUDs may be ineffective and unsafe. In the letter, the FDA said it…
[...]28 Doctors in 10 Rhode Island Practices Investigated for Purchasing Misbranded IUDs
The Rhode Island Department of Health announced an investigation of 28 providers in 10 Rhode Island OB-GYN medical offices who had illegally imported non-FDA approved IUDs and inserted them into patients. Among the practices named were OB-GYN Associates, Inc, Bayside OB-GYN, Inc., and Center for Obstetrics & Gynecology, Inc. The Rhode Island Department of Health…
[...]2 Million Counterfeit Needles Found in Europe
View larger map What: More than two million counterfeit insulin needles were found in established European distribution channels. When: July 1, 2009 Where: Netherlands, Poland and the United Kingdom How: A Dutch company purchased insulin needles from a wholesaler in Malaysia, which claimed the needles came from Iran. The needles were subsequently distributed throughout the…
[...]Warning for Counterfeit Insulin Pens
Health Care Inspectorate Warns of Counterfeit Insulin Needles Products counterfeited: Insulin needles Lot numbers: 08J02S Countries known affected: Netherlands, UK, Poland Investigating agency contact: Inspectie Voor de Gezondheidszorg Manufacturers information: Novo Nordisk Posted on/updated: July 2009 View Larger Map The Netherlands Health Care Inspectorate [Inspectie voor de Gezondheidszorg (IGZ)] has issued a public warning following…
[...]Dr. Bayardo Cruz Pleads Guilty in California Fake IUD Case
Dr. Bayardo Cruz pleaded guilty to purchasing imported Mexican IUDs from a company called Universal Services. These devices cost $30 each, a substantial discount from the FDA approved versions, which ranged from $300 – $400 each. Cruz inserted 110 of the black market IUDs in his patients, but continued to bill Medi-Cal for the legitimate…
[...]Counterfeit Insulin Needles Found in the UK
Counterfeit Insulin Needles Found in UK View Larger Map What: A batch of counterfeit insulin pen needles emulating those made by Novo Nordisk were discovered in the United Kingdom. According to the Juvenile Diabetes Research Foundation in England, “the needles were not made by Novo Nordisk, the manufacturer of NovoFine® and do not comply with…
[...]Counterfeit Product May Affect Diabetics
Phony copies of blood testing strips used by millions of diabetics in the U.S. came from China. The counterfeit test strips were sold last year under the brand names "One-Touch Ultra" and "One-Touch" basic. Johnson & Johnson's Life Scan makes the real products. The company says it discovered the bogus strips after customers called to…
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