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 […]
Recalls
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 […]
Amneal Pharmaceuticals issues voluntary recall of lorazepam droppers
Amneal Pharmaceuticals said today that it is voluntarily recalling 13 lots of its oral lorazepam product due to a defect in the dosing dropper. In some cases, the dropper is printed with the dose markings in reverse order or has no dose markings at all, according to the Bridgewater, N.J.-based company. So far, no adverse […]
Novo Nordisk recalls cartridge holders in insulin delivery devices
Novo Nordisk (NYSE:NVO) launched a recall yesterday of insulin cartridge holders used in select batches of NovoPen Echo insulin delivery devices. The company said the cartridge holders could crack or break upon exposure to certain chemicals. Using a NovoPen Echo with a cracked or broken cartridge holder could result in the device delivering a lower dose […]
BD recalls select Plastipak catheter tip syringes over leakage issues
Becton Dickinson (NYSE: BDX) is initiating a voluntary product recall for its 100ml Plastipak catheter tip syringes over leakage issues the company caught during testing. The Franklin Lakes, N.J. company discovered that the devices, which are labeled with a 5-year expiration date, were found to be failing during routine real-time stability tests, beginning at the […]
Magellan widens lead test recall
The FDA this week expanded its Class I recall of lead poisoning tests from Magellan Diagnostics to include 2 additional testing systems. The regulatory watchdog said it recalled Magellan’s LeadCare testing systems because they may underestimate blood lead levels and provide inaccurate results with venous blood samples. “Falsely lower test results may lead to improper patient […]
Medtronic updates 2011 battery warning on Synchromed II implantable drug pumps
Medtronic (NYSE:MDT) this month updated physicians on a warning it 1st issued in July 2011 about the batteries in its SynchroMed II implantable drug infusion pump. The pumps are used primarily to treat chronic pain or severe spinal or cerebral spasticity. The issue, 1st reported in July 2009, relates to the formation of a filmy substance within the […]
CareFusion recalls IV sets on cracked back-check valves
Becton Dickinson subsidiary CareFusion recalled some IV sets today after reports that cracks in the secondary set back-check valve caused infusion fluid to leak. The company said the secondary sets are attached to a needle-free device that has been cleaned with isopropyl alcohol and CareFusion thinks that causes the plastic to crack. Leakage in the back-check valve connection […]
Abbott to restrict Absorb bioresorbable stent in Europe
Abbott (NYSE:ABT) plans to restrict the use of its Absorb bioresorbable stent in Europe after a clinical study found a higher risk of serious adverse events. In a March 31 letter to physicians (posted online April 5 by a prominent cardiologist from Atlanta), Abbott said it would restrict use of the Absorb and Absorb GT1 devices to […]
