Days after classifying one recall for the Alaris infusion pump, the FDA has issued another Class I recall for the device.
On Friday of last week, the FDA issued a Class I recall — the most serious kind — for the BD (NYSE:BDX) Alaris because there is a risk of the keypad lifting up due to fluid entry, an issue that could result in keys that become unresponsive or stuck. BD initiated that recall on March 3, 2021.
Today, the FDA labeled another recall for the infusion pump, serviced by Tenacore, as Class I, with this one having been initiated by the company on Feb. 25, 2021.
Tenacore recalled the Alaris pump because the bezel repair posts may crack or separate, leading to the inaccurate delivery of fluids to patients. The separation of one or more bezel repair posts could result in the free flow of fluids to patients, over- or under-delivery of fluids, interruption of fluid delivery, device leaks, device component burning or smoking and/or power supply failure or malfunction.
Any or all of the issues could cause serious patient harm. Two complaints about the device issue were reported with no injuries or deaths registered.
The Alaris infusion pumps serviced by Tenacore that were recalled were Model 8100 devices. They were distributed between July 10, 2020, and Feb. 18, 2021. To date, 474 devices have been recalled in the U.S., according to an FDA release.