Drugs

FDA Safety Alert on Some BD Alaris Pump Modules

FDA has issued a safety alert after Becton Dickinson (BD) recently recalled (Class 1 device correction) certain Alaris Pump Modules if they have been dropped or severely jarred, citing risks of inaccurate drug delivery that could lead to serious injury or death. The company notified customers 10/17 that the modules and related bezel assembly kits may suffer internal damage when dropped — even if no exterior damage is visible. The company said such damage can impair the pump’s bezel assembly, a structural component critical to maintaining correct flow rates.

According to BD, a damaged pump could deliver too little or too much medication, allow unregulated flow, or fail to calibrate. Those failures could result in “serious adverse health consequences including serious injury and death,” depending on the drug involved and the patient’s condition, it says. As of 9/22, BD has reported two serious injuries linked to the issue.

The BD Alaris System is a modular infusion platform used to administer fluids, including medications, to adult, pediatric, and neonatal patients through routes such as IV, intra-arterial, subcutaneous, or epidural infusion. The affected product codes include the Alaris Pump Module 8100 and several associated bezel assembly kits.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome