The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris PC unit is Class I, the most serious kind.
Initiated on Aug. 4, 2020, the recall pertains to the BD Alaris PC unit 8015 and five affected keypad replacement kits manufactured between April 7, 2017 and June 15, 2020 and distributed between April 12, 2017 and June 25, 2020. A total of 305,526 devices have been recalled in the U.S., according to an FDA release.
BD is recalling the Alaris PC unit and the PC unit front case with keypad replacement kits because the keypad may have one or more keys in the keypad that become unresponsive or stuck, which could lead to an infusion delay or prevent clinicians from changing the fluid or medication infusions on the affected device.
Use of the affected Alaris infusion pump units could cause serious adverse events, including death, although no deaths have been reported to date. So far, there have been 1,186 reported complaints about the issue and one reported injury.
The company informed clinical users that the affected devices should be removed from service and sent to their biomedical engineering staff if the PC unit keypad becomes unresponsive or a key gets stuck. They may continue the infusion until it is safe to replace the PC unit if they are administering a critical medication.
Cleaning personnel were told to avoid use of a cloth that drips, wringing out the cleaning cloth to squeeze out fluid, and not to spray fluids directly onto the device to minimize the potential for fluid entry during cleaning.
BD told biomedical engineers to inspect all PC unit keypads for bubbling, cracks, damage, layer separations and holes, replacing the front case keypad if it fails inspection.
Last month, BD confirmed three separate issues related to an earlier recall of its BD Alaris infusion pumps that were listed as Class I recalls. It was also recalled back in February for multiple issues.