Medline Industries, LP: Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breat
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respiratory gas humidifier.
- Reason / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Panama.
- Recall initiated
- 2026-07-13
- Code info
- All lot codes
- Product quantity
- 20 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 99403
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