FDA officials put their highest-risk Class I label on a recall of certain Merit Medical Systems (NSDQ:MMSI) procedural trays and kits over concerns about 1% Lidocaine HCl injections manufactured by Hospira (NYSE:HSP).
The injections were recalled after 1 confirmed customer report of red and black particulate in the container, according to the FDA memo. The debris was identified as oxidized stainless steel, which agency officials said could present a risk of injury or death to patients.
"The presence of oxidized stainless steel particulate may potentially put a patient at risk from a strong magnetic field exposure such as with magnetic resonance imaging," according to the recall memo. "If a metal particle in the lung becomes dislodged and pulled through tissue, possibly causing a collapsed lung (pneumothorax) or blood in the space between the chest wall (hemothorax), urgent and significant medical intervention may be required. The presence of oxidized stainless steel particulate could also result in blood clots in the lung and a stroke"
Merit Medical initiated recall efforts in September 2013 with an urgent notice to its customers, who have the choice to return the affected trays in their entirety or choose to use them and just ditch the Lidocaine.
Hospira issued a nationwide recall in October, noting at the time that there were no reports of adverse events associated with the issue.
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