Clinical Trials
0
0 active
Approvals
38
Total approvals
Agencies
2
Regulatory bodies
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- The FDA posted a Class I classification on Sept. 14 for an AVID Medical Halyard IV start kit containing a skin prep applicator contaminated with a fungus. - The recall covers 288 units of lot 1658437 distributed in Nebraska, tracing to BD ChloraPrep Clear 1 mL applicators from lot 4032183. - No injuries or deaths have been reported, and the FDA lists the cause as packaging process control at the applicator manufacturer.
- The FDA issued an early alert on September 3 for the Draeger VentStar Resus Neo breathing circuit, model MP00310, after the manufacturer found the hoses can crack. - Draeger told customers on September 1 to inspect each hose before use and discard any with cracks or a detached hose, with no returns required. - The FDA said a cracked hose may leak or fall off, restricting ventilation or delaying therapy and potentially causing hypoxia or death, though no serious injuries or deaths were reported as of August 27.
- The FDA assigned a Class II severity rating to the recall of Medline's Hudson RCI neonatal and infant heated wire breathing circuits, placing it in the middle of the agency's three-tier risk system. - The recall stems from sporadic failures at the heated-wire connector, where circuits can discolor, melt, smoke, or emit a burning odor at the point of connection to the Neptune humidifier. - A built-in safety feature cuts power to the heated wires when electrical abnormalities are detected, so respiratory gas flow continues and only the warming and humidification function stops. - Medline reported no serious injuries or deaths associated with the issue as of July 31, though hospitals face a dual item-numbering problem that could cause affected stock to be missed.
- Precipio (PRPO) combines clinical laboratory services with proprietary diagnostic product development, with pathology services focused primarily on hematologic cancers. - Biodesix (BDSX) provides blood-based diagnostic testing for lung disease, including tests that assess cancer risk in lung nodules and guide post-diagnosis treatment. - Biodesix has outperformed Precipio over the past three months (up 64.5% vs. 26.4%) and over the past year (up 150.9% vs. 112%). - Both stocks trade below the Zacks Medical sector average EV/S of 2.92X, with PRPO at 1.90X and BDSX at 2.89X.
- Medline is recalling Namic angiographic rotating adaptor control syringes due to devices becoming loose or disconnected during use, potentially causing air embolisms and biohazard exposure. - The FDA issued a warning letter after finding that Medline did not take adequate action despite receiving 250 complaints and reports of four serious injuries between June 2023 and February 2024. - Manufacturing issues including excess silicone contamination and inadequate cleanroom maintenance at Medline's Glen Falls facility contributed to the device failures. - Clinicians may only use the recalled devices in urgent situations with no alternatives available, requiring extreme caution and manual stabilization throughout procedures.
