Medline Hudson RCI heated breathing circuits recalled for connector failure risk in neonates and infants
What this means
Medline's Hudson RCI heated breathing circuits for newborns and infants may experience sporadic failure in the heated wire connector at the humidifier. The connector can show discoloration, melting, smoke, or burning odor. This failure could reduce oxygen delivery and increase risk of airway problems in infants using the device.
- Check your device against the product numbers listed (HUD78001KIT, HUD78007KIT, HUD78008KIT, HUD78009KIT, HUD78017KIT, HUD78018KIT, HUD88001KIT, HUD88013KIT, HUD88014KIT, HUD88015KIT, or HUD88017KIT).
- Inspect the heated wire connector (pigtail) for discoloration, melting, smoke, or burning odor before each use.
- Contact Medline or your equipment provider for a replacement or instructions.
- Report any observed connector damage or device malfunction to Medline and the FDA.
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-2993-2026More Medline recalls
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