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-C
Check against the official notice below — it lists the full affected range.
Medline Industries, LP is recalling neonatal and infant heated wire breathing circuits sold under the Hudson RCI brand name due to a hazard where the heated wire connector at the humidifier may experience sporadic failure, exhibiting signs such as discoloration, melting, smoke, or burning odor. The affected breathing circuits, distributed nationwide in the US and in Panama, include six product numbers (HUD78007, HUD78009, 780-13, 780-14, 780-15, and HUD78018) with all lot numbers of each product involved. A total of 145,525 units have been distributed.
Device failure may cause infants to experience bronchospasm, inspissated secretions, airway obstruction, inadvertent positive end-expiratory pressure, circuit obstruction, accidental fluid lavage into the airway, elevated oxygen consumption, and worsening respiratory distress. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide and the country of Panama. Quantity: 145525 units Lot/code info: 1) Medline Product Number/SKU HUD78007, UDI/DI 10197344042463 (each) 20197344042460 (case), All lot numbers; 2) Medline Product Number/SKU HUD78009, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 3) Medline Product Number/SKU 780-13, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 4) Medline Product Number/SKU 780-14, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 5) Medline Product Number/SKU 780-15, UDI/DI Discontinued (each) Discontinued (case), All lot numbers; 6) Medline Product Number/SKU HUD78018, UDI/DI 10197344010660 (each) 20197344010667 (case), All lot numbers.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.