in february 2010 bd announced a voluntary product recall of certain lots of bd q-syte luer access devices and bd nexiva closed iv catheter systems. bd stated that the use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. the approximately 2.8 million bd q-syte and 2.9 million bd nexiva units containing 5 million bd q-syte devices that were recalled were distributed in the united states, asia, canada, europe, mexico, the middle east, south africa, and south america. the recall was initiated on oct. 28, 2009 after bd received complaints of problems due to air entry through a part of the device. bd stated that the cause of the problem was manufacturing deviation and claimed that it corrected the problem. bd announced that it notified customers about the recall by letter and has been working with the u.s. food and drug administration and worldwide health agencies to coordinate recall activities.