Teva Pharmaceuticals (NYSE:TEVA) initiated a voluntary recall of a lot of its Topotecan injection 4mg/4mL (1mg/mL) in the U.S. The voluntary recall came as a result of a complaint received from a pharmacy after a single glass particle was observed inside one vial. Following further examination of the complaint sample, two other particulates were found […]
Recalls
Smiths Medical recalls some insulin syringes over skewed graduation marking
Smiths Medical announced today that it issued recall notices for its Jelco Hypodermic Needle-Pro fixed needle insulin syringes. Minneapolis-based Smiths Medical became aware of specific models and lots of the Jelco Hypodermic Needle-Pro fixed needle syringes that may exhibit skewed odd number line graduation markings on their syringe barrels. The company identified markings skewed upward […]
BD applicators cited in medical kit recall
A medical care kit company is recalling more than 8,200 kits because they contain BD applicators that may become contaminated with a fungus. The recall by Medical Action Industries covers certain of its 306 Medical Convenience Kits, distributed between December 12, 2019, and March 22, 2021, according to the FDA. The agency has labeled the […]
BD’s Alaris pump hit with another serious recall
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 […]
Pump problem prompts another Alaris recall
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 […]
Another BD Alaris infusion pump recall is Class I
The FDA has identified another recall for the Alaris infusion pump from BD (NYSE:BDX) as Class I, the most serious kind of recall. BD’s latest recall, initiated on March 3, 2021, involves its BD Alaris infusion pump module system, which includes an infusion pump and vital signs monitoring system with a PC unit, the Guardrails […]
BD expands recall of ChloraPrep 3 ml applicator
BD announced that it revised a previous press release from last week to expand a voluntary recall of its ChloraPrep 3 mL applicator. Franklin Lakes, N.J.-based BD initiated the recall for specified catalog numbers of the applicator device on June 23, 2020, due to possible fungal contamination under certain environmental conditions, according to a news […]
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 […]
Baxter has a serious infusion pump recall
Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries. So far, Baxter has received 16 reports of serious injuries related to the problem. FDA has labeled the recall as Class I, its most serious level. […]
BD warns on some ambulatory syringe pumps
Becton Dickinson (NYSE:BDX) issued a field safety notice in the United Kingdom to warn on an issue with its T34 and T34L (T60) ambulatory syringe pumps. The company was alerted to an issue with the syringe pumps that could cause risk of under-infusion and/or alarm failure, according to the notice published today. Users of the syringe […]
