A medical supply company is recalling BD (NYSE:BDX) Alaris infusion pumps — the third Class I recall for the pumps in recent months, according to the FDA.
North Carolina-based Avante Health Solutions issued the Alaris pump recall March 24, 2021, 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.
The latest recall of Alaris Model 8100 covers 2,452 pumps distributed between July 10, 2020, and February 18, 2021. There have been 62 complaints reported about this device issue and one death may have been related to this recall, according to an FDA news release. No other injuries have been reported.
Medical device service company Tenacore issued a recall on Alaris for the same reasons on Feb 25, 2021. BD initiated its own recall on March 3, 2021 for an unrelated issue — the risk of the keypad lifting up due to fluid entry, an issue that could result in keys that become unresponsive or stuck.
The FDA has labeled all three recalls Class I, the most serious kind.
BD announced on April 26 that it has applied to the FDA for a new clearance for Alaris infusion pump system. BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March 2020. Pumps are only going to health providers with an immediate medical need.
