BD (NYSE:BDX) announced that it issued a voluntary recall for select lots of a trio of its intraosseous products.
Franklin Lakes, New Jersey-based BD’s recall covers its Intraosseous Needle Set Kits, Intraosseous Manual Driver Kits and Intraosseous Powered Drivers.
According to a news release, certain lots within the expiration date of the affected products may result in a series of potential issues. There may be difficulty separating the stylet from the intraosseous needle where the increased force required to remove the stylet from the intraosseous needle results in inadvertent removal of the entire needle assembly during placement or the inability to remove the stylet from an indwelling intraosseous needle, both resulting in the functional loss of intraosseous access.
Additionally, users may experience an issue in which the needle safety mechanism on the stylet does not deploy after the placement of the intraosseous needle and removal of the stylet from the needle. Metal discs intended to connect the needle assembly to the magnet in the powered driver may also stick unexpectedly to the magnet, rendering the driver unusable.
The issues affecting the needle kits and driver kits may result in delays in care due to limited or non-functioning intraosseous access or could also result in needlestick injuries.
These issues may result in delays in care due to limited or non-functioning intraosseous access or could also lead to needlestick injuries.
BD instructed customers to immediately review inventory for the catalog and lot numbers listed in the recall notice. Affected needle kits should be destroyed in compliance with the healthcare institution’s process for disposal.
Use of affected intraosseous powered drivers should be paused until a BD representative provides instruction that it is safe for use. The company said its representatives will be contacting customers for inspection and will repair the devices if required.
No replacement products currently exist, so BD recommends that customers evaluate their clinical needs and consider obtaining and using an alternative intraosseous product. The company will notify customers when replacement products are made available.