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- 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.
