Medline Industries, LP — Class II: Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Me
Medline Industries, LP has initiated a Class II recall for specific Hudson RCI neonatal heated wire breathing circuits due to localized thermal damage at the humidifier pigtail connector. Affected devices may exhibit melting, smoke, or discoloration, potentially leading to circuit obstruction or respiratory distress.
Medline Industries, LP, Teleflex, neonatal intensive care units, respiratory therapy departments, and clinical engineering teams managing neonatal ventilation equipment.
The failure mode—localized thermal damage—poses significant clinical risks to a vulnerable neonatal population, including potential airway obstruction and bronchospasm. From a regulatory perspective, this suggests a critical failure in the electrical or material interface of the heated wire component, necessitating thorough CAPA investigation into component specifications or manufacturing tolerances.
Immediately identify and quarantine affected SKU numbers (HUD78007, HUD78009, 780-13, 780-14, 780-15, 780-18) and initiate reconciliation of inventory. Review post-market surveillance data for similar thermal damage reports in other heated wire circuit product lines.
Class II. Reason: 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.. Product: Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).. Firm: Medline Industries, LP (Northfield IL United States). Status: Ongoing.
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