A new report published this week by the International Consortium of Investigative Journalists and media organizations around the world took aim at medical device companies and the regulations that govern the $400 billion industry. And in a related report about Medtronic (NYSE:MDT), the authors zero in on the company’s diabetes unit and its insulin pumps. Over the […]
Recalls
Fresenius Kabi recalls sodium chloride injections over latex concern
Fresenius Kabi USA voluntarily recalled 163 lots of sodium chloride injections last week, noting that the product contains latex despite an insert that states otherwise. The company’s recall includes 0.9% injections in 10 mL vials and 20 mL vials. The product insert and the tray label for both kinds of vials say that the products’ stoppers […]
FDA recalls heart failure, blood pressure drugs due to cancerous contaminant
The FDA announced last week a voluntary recall of several high blood pressure and heart failure medications containing valsartan due to a cancerous impurity. Some valsartan drugs were found to contain N-nitrosodimethylamine (NDMA), a compound that is classified as a probable human carcinogen. Not all drugs containing valsartan were recalled, the FDA noted. Teva Pharmaceuticals (NYSE:TEVA), […]
Hospira issues nationwide recall for opioid overdose reversal drug
Pfizer‘s (NYSE:PFE) Hospira unit this week voluntarily recalled two lots of a drug used to reverse the course of an opioid overdose. The company’s naloxone injection, sold in its Carpuject single-use cartridge syringe, was recalled due to the potential presence of embedded and loose particulate matter in the plunger. Hospira specifically warned that products from lots 72680LL and 76510LL […]
Medical device recalls significantly increase during Q1
The medical device and pharmaceutical industries saw a significant spike in product recalls during the first quarter of 2018, according to the U.S. Recall Index released by Stericycle Expert Solutions. There was a 126% increase in medical device recalls in Q1 — the most in a quarter since 2005. Software problems made up about 22.7% […]
Manufacturing fault prompts BD to recall blood collection tubes
Becton Dickinson‘s (NYSE: BDX) life sciences division issued a recall last month for some of its blood collection tubes, citing a manufacturing flaw that resulted in devices without sufficient additive. The company explained that an internal investigation found that Vacutainer Citrate Plus tubes with too little additive led to falsely-shortened clotting time and could impact patient […]
FDA to expedite release of recall information
By: Douglas Stearn, J.D. When FDA identifies that a product it regulates violates the law, it protects the public by working with the manufacturer and distributors to facilitate the product’s recall (i.e., removal from the marketplace or product correction). Among other actions, FDA assures that the public is warned when products present the most significant […]
Smiths updates recall for Medfusion syringe pumps
Smiths Medical has amended an urgent medical device recall that it first issued in August for its Medfusion syringe pump model series 3500 and 4000. After acknowledging that a defect in certain models of the pump can cause an “invalid syringe size” alarm to go off, the company added an option for facilities with trained […]
Boston Scientific recalls certain sizes of Eluvia, Innova stents
Boston Scientific (NYSE:BSX) has initiated a voluntary recall of its 150mm Eluvia drug-eluting vascular stent, as well as its 180mm and 200mm Innova self-expanding stent system, according to a document filed by the Federal Institute for Drugs and Medical Devices in Germany. The company said it was pulling these particular devices due to the number of […]
Medtronic recalls insulin infusion sets
Medtronic (NYSE:MDT) said today that it’s recalling some of the infusion sets used with its insulin pumps due to problems with a discontinued component. The Fridley, Minn.-based medical device titan said the problem involves a vent membrane that’s susceptible to blockage during priming and fill-tubing. No pumps or glucose sensors are affected by the recall, Medtronic […]
