The affected products were manufactured April 29 through August 20, 2013 and distributed through Sept. 20, 2013. There has been one confirmed customer report of visible particulate, oxidized stainless steel, identified in the primary product container. If the oxidized stainless steel particulate is detected, there is a potential to be injected and/or result in delay in therapy.
The oxidized steel particulate may also put a patient at risk from a strong magnetic field exposure in MRI. The presence of oxidized stainless steel particulate could also result in blood clots in the lung and a stroke.
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