Yesterday, the FDA issued a safety alert warning of ReFlow Medical’s 4/22/17 lot-specific voluntary recall of its Wingman35 Crossing Catheters distributed between January 2015 and March 2016. According to the FDA, the Wingman35 Crossing Catheters have been found to exhibit tip splitting or separation, which has resulted in two adverse events. Tip splitting has the...
Today the FDA reported that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder System Humeral Tray Model 115340 because “these devices are fracturing at a higher rate than is stated in the labeling. Fractures may result in revision surgeries which could cause serious adverse health consequences such as permanent loss of shoulder function, infection, or rarely,...
On Friday, the FDA reported that Meijer was recalling Meijer Brand Colby and Colby Jack Deli Cheese sold exclusively through its deli counters from November 10, 2016 to February 9, 2017 due to a potential contamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly...
On February 7, 2017, the FDA warned: Kingsway Trading Inc. of Brooklyn, NY is recalling its 1.06 oz (30g) bottles of “Well Balance Xanthium & Siler Combo (Bi Yan Pian)” Batch No. 130401 & Batch No. 150201 because they contain the presence of undeclared Ephedra Herba (ma huang), an FDA banned item. Dietary supplements containing...
On January 13, 2017, Physio-Control, a provider of professional emergency medical response solutions, announced a voluntary field action for the LIFEPAK 1000 defibrillator due to reported instances where the device has shut down unexpectedly during patient treatment. The company admits that it has received 34 reports where customers have attempted to use their LIFEPAK 1000...
On August 29, 2016, Stryker Corporation issued an urgent medical device recall related to its Stryker LFIT Anatomic CoCr V40 series of femoral heads due to “higher than expected complaints of taper lock failure.” These femoral heads are used in a number of the company’s modular hip replacement systems (used in hip replacement procedures) such...
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