Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action.
Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, blood and blood products in the NICU.
“The recall is being conducted due to leaking of the syringe administration set, which may result in delay or interruption of infusion, under-infusion, contamination of the fluid path and [healthcare provider] exposure to infusates,” the company said at the time of the recall.
The leaks can occur during infusion or priming, with one droplet appearing about every 10 seconds in the inlet and/or outlet of the tubing to the filter engagement, BD said, adding that all products affected by the recall, which were manufactured in April 2018 and distributed between May 11, 2018 and Sept. 14, 2018, should be destroyed.
The FDA gave the recall Class I status, denoting the risk of serious injury or death, although no adverse events have been reported so far in connection with the leak issue.