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Alaris

BD begins remediation in Alaris infusion system software recall

July 29, 2021 By Sean Whooley

BD Alaris infusion pump

BD (NYSE:BDX) announced today that it will begin remediation for a 2020 Class I-level recall of its Alaris infusion system. Franklin Lakes, N.J.–based 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, with pumps only going to health providers […]

Filed Under: Auto-injectors, Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: Alaris, BD, FDA

BD’s Alaris pump hit with another serious recall

April 30, 2021 By Nancy Crotti

BD Alaris infusion pump

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 […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls Tagged With: Alaris, Avante Health Solutions, BD, FDA, Tenacore

Pump problem prompts another Alaris recall

April 19, 2021 By Sean Whooley

Tenacore

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 […]

Filed Under: Auto-injectors, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: Alaris, BD, Tenacore

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