| Recall Number | Z-2991-2026 |
|---|---|
| Recalling Firm | Medline Industries, LP |
| Classification | Class II |
| Voluntary / Mandated | Voluntary: Firm initiated |
| Distribution Pattern | Worldwide distribution - US Nationwide and the country of Panama. |
| Status | Ongoing |
| Device Class | N/A |
| Device Name | N/A |
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit
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.
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