Fresenius Medical Care North America had to notify customers of leakage from its Optiflux dialyzers. Model numbers ranged from the F160NRe to the F18Nre in the series; six models total. The company said it had notified customers in February that, in some cases, the dialysate port caps on the hemodialyzer do not form a tight seal when normal torque is applied, “and we advised them that if they encounter a resulting saline leak during pre-treatment priming, they should secure the cap beyond the thread stop,” FMCNA spokesperson Jonathan Stone told NN&I. The FDA recall classification does not involve removing any products from the market, said Stone.
Other Class 2 recalls
Winco Manufacturing LLC has recalled four models of its medical chair because of problems with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.
NxStage Medical has identified over 900 mislabeled cases of its Pure Flow-B solution. Product is packaged in a case containing two individual 5L bags.