Devices

Class 1 Recall of Smiths CADD Infusion Sets

FDA has classified as Class 1 a Smiths Medical recall associated with a 12/2022 company-issued “urgent medical device correction” letter identifying two potential issues with CADD Infusion System Infusion Sets due to lack of delivery or underdelivery and false “no disposable attached (NDA)” alarms. A recall notice details the issues, the affected items, the required steps to perform, and specific instructions for treatment of patients requiring life sustaining therapy.

The lack of delivery or underdelivery issue may occur due to manufacturing variations that can cause the green CADD Flow Stop arm to compress partially that can occlude the tubing before clinical use, the company says. “If this happens, there is a potential that the occlusion does not resolve when the CADD reservoir or administration set is connected to the pump, and the pump may not detect the occlusion.” The occlusion may result in underdelivery or non-delivery of medication, despite the pump displaying that the infusion is running properly, it explains.

The NDA alarm issue is isolated to CADD legacy pumps, which Smiths Medical announced will be discontinued effective 12/31. “There is a potential that CADD legacy pumps may not detect that 50 mL and 100 mL CADD Medication Cassette Reservoirs with a Flow Stop are attached to the pump when they are properly attached,” the company says. In this instance, the pump will initiate an NDA alarm if the NDA double-beep warning is not resolved within two minutes. The user must clear the alarm and resolve the cause of the NDA event before using the pump.

A copy of the customer notification can be found here.

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

Read more

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