Devices

Becton Dickinson Expands Alaris Pump Recall

Becton Dickinson has expanded the Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing potential performance issues that could lead to serious injury or death in vulnerable patients. The recall, first initiated on 7/8 and expanded on 7/17, now covers discontinued pump infusion sets that may still be in circulation, an agency update says.

According to the company, internal testing revealed that the affected infusion sets may not perform as described in the user manual under certain conditions. Potential issues include:

Inaccurate flow rate and bolus dose delivery, leading to under- or over-infusion
Delayed occlusion alarms
Excess post-occlusion bolus volume, which could result in over-infusion

These problems could compromise dose accuracy and infusion performance, especially in critically ill patients and neonates, the update says.

The company has issued updated corrective actions and risk information to customers and urged facilities to check inventory for the discontinued sets.

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