Continuous glucose monitors (CGMs) are among the most potent diabetes management tools to emerge in recent decades. FDA approved the first professional CGM in 1999, and the technology has evolved swiftly since then. Current models beam data via Bluetooth to smartphones (plus the Apple Watch) and the cloud, enabling patients to explore their blood glucose […]
Drug Pumps
Alaris remediation could cost BD up to $244M
Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps. The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to […]
Feds flag BD’s Alaris pumps for cybersecurity issues
Becton Dickinson (NYSE:BDX) last week issued a notice to warn on potential vulnerabilities with its Alaris infusion pumps. The notification applies to BD’s Alaris PC unit, model 8015, versions 9.33.1 and earlier, as well as the Alaris systems manager, versions 4.33 and earlier, according to a news release. BD was made aware of a network session […]
Baxter lands major DoD contract
The U.S. Defense Dept. (DoD) announced that it awarded Baxter (NYSE:BAX) $40 million for its infusion pumps and accessories. Baxter’s contract includes a maximum $40 million fixed-price award with economic-price-adjustment and indefinite-delivery/indefinite-quantity for its infusion pumps and accessories. The competitive acquisition had 105 offers received. Get the full story at our sister site, Drug Delivery Business […]
BD beats The Street in Q4, posts 2021 guidance
Becton Dickinson (NYSE:BDX) reported Street-beating fourth-quarter financial results and revealed its 2021 fiscal guidance. The Franklin Lakes, N.J.-based company posted profits of $128 million, or 36¢ per share, on sales of $4.8 billion for the three months ended Sept. 30, 2020, for a -21.5% bottom-line slide on sales growth of 4.4%. Adjusted to exclude one-time items, […]
Medtronic must face infusion pump lawsuit
A federal judge in Missouri has blocked an effort by Medtronic (NYSE:MDT) to dismiss a lawsuit alleging that the failure of one of its infusion pumps caused “severe and permanent injuries.” Plaintiff Carissa Sullivan, who has cerebral palsy and spastic quadriplegia, claims that the SynchroMed II infusion pump she had implanted in 2011 failed in 2015, […]
FDA labels another BD Alaris recall Class I
The FDA announced today that the August recall of a Becton Dickinson (NYSE:BDX) Alaris pump module is Class I, the most serious kind. BD Alaris pump module model 8100 and the Alaris pump module door assembly replacement kits (part numbers 49000346, 49000239, 49000438 and 49000439) were included in the Aug. 4 recall. Those models and parts were […]
BD has another Class I infusion device recall
The FDA issued another Class I recall designation for the BD Alaris from Becton Dickinson (NYSE:BDX), this time for potentially incorrect displays. Recalled products include the BD Alaris syringe module (model 8110) and BD Alaris PCA module (model 8120), and the BD Alaris syringe/PCA sizer sensor replacement kit (P/N 122786). Affected products related to the infusion […]
BD has a serious recall of some Alaris System infusion pumps with stuck keys
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 […]
BD says 3 serious issues related to Alaris recall
Becton Dickinson (NYSE:BDX) today offered an update confirming three separate issues related to the recall of its BD Alaris infusion pumps. Three situations described in the recall, which was announced on June 30, were designated as FDA Class I recalls (the most serious kind), meaning that there is reasonable probability that use of the product will […]
Smiths Medical has a serious infusion pump recall
Smiths Medical announced that it has become aware of an issue in which certain Medfusion syringe pumps may not operate as expected. Minneapolis-based Smiths Medical said in a news release that certain Medfusion 3500 and 4000 syringe pumps with specific firmware versions may provide over-delivery or under-delivery of a bolus or loading dose when one […]
