Effective immediately, the Centers for Medicare & Medicaid Services (CMS) is removing OP-16 Troponin results for emergency department acute myocardial infarction (AMI) patients or chest pain patients (with probable cardiac chest pain) received within 60 minutes of arrival from its hospital Outpatient Quality Reporting (OQR) program. (more…)
September 10th, 2012
A federal court in South Carolina has rejected two medical device distributors’ requests to dismiss a lawsuit holding them accountable for post-op complications due to the use of counterfeit surgical mesh they supplied to a surgical facility.
The mesh, supplied by Ram Medical and Medline Industries, was labeled and sold as C. R. Bard/Davol brand name surgical mesh, but is believed to be counterfeit mesh made in China. This kind of surgical mesh is used to reinforce weak soft tissue, such as for hernia repair and chest wall defects.
September 16th, 2011
Cumberland Pharmaceuticals Inc. is recalling six lots of Acetadote (acetylcysteine) injection. The 20 percent solution (200 mg/mL), 30 mL single dose glass vials are being recalled because of particulate matter observed in a “very small” number of vials, the drugmaker says in a press release.
Used in the emergency department (ED), Acetadote (HCPCS Level II code J0132 Injection, acetylcysteine, 100 mg) is administered intravenously within eight to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen to prevent or lessen hepatic injury. Acetadote is the only injectable product approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter painkillers.
The lot numbers being recalled are: 090304 (expiration Feb. 2011), 090331 (expiration Feb. 2011), 090401 (expiration March 2011), 090511 (expiration April 2011), 090602 (expiration May 2011), and 090616 (expiration May 2011).
In other news: Cumberland Pharmaceuticals announced Jan. 13 that it has received approval from the U.S. Food and Drug Administration (FDA) for a new formulation of Acetadote injection.
The new formulation does not contain ethylenediaminetetracetic acid (EDTA) or any other stabilization and chelating agents and is preservative-free.
January 28th, 2011
The U.S. Food and Drug Administration (FDA), July 13, ordered Baxter Healthcare Corp. to recall all Colleague infusion pumps after determining deficiencies in the pumps would not be corrected in a reasonable timeframe. According to a proposed correction schedule submitted to the FDA, Baxter did not intend to begin correcting the pumps until May 2012.
The FDA has ordered Baxter to recall and destroy all Colleague infusion pumps in the United States and to provide customers with either a replacement infusion pump (other than the Colleague model) or a refund no later than July 13, 2012.
See the FDA final order for information about how to receive a refund or replacement pumps.
July 16th, 2010
Nearly a million doses of H1N1 vaccine for infants and toddlers (ages 6 months – 3 years) were recalled on Tuesday. The vaccine reportedly lost strength since its distribution throughout the country last month. The vaccine was strong when the shots were originally shipped, according to the manufacturer, Sanofi Pasteur; however, tests done weeks later revealed the potency had fallen about 12 percent below the government standard.
By now, most of the shipment has already been used, but doctors are asked to return any unused doses.
Officials with the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and Sanofi Pasteur say the strength of the vaccine is still high enough to protect children who received it. Parents can rest assured that already injected vaccine dosages are safe and effective, according to Dr. Anne Schuchat, a CDC flu expert.
December 15th, 2009