Medline Hudson RCI neonatal heated breathing circuits recalled for connector failure risk
What this means
Medline's heated wire breathing circuits for newborns and infants may fail unexpectedly. The heated connector at the humidifier can discolor, melt, or show signs of heat damage, which could cause the circuit to stop working or allow fluid to enter the airway.
- Check your neonatal breathing circuit for the product numbers listed: HUD78007, HUD78009, 780-13, 780-14, 780-15, or HUD78018
- If you have one of these circuits, stop using it and contact Medline or your equipment supplier
- Contact your hospital or clinic's biomedical or respiratory equipment team to report and replace affected units
The agency's original wording
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2992-2026More Medline recalls
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