HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
Check against the official notice below — it lists the full affected range.
Teleflex Medical Inc. is recalling approximately 30,566 units of the Hudson RCI Comfort Flo Corrugated Humidification System (model REF 2415) that were distributed nationwide. The humidifier nebulizer kit has a defect that could allow water to flood the column and enter the breathing circuit when abnormal pressure differences develop between the water bottle and column during high flow oxygen therapy. The affected devices are identified by GTIN 14026704659361 and specific lot numbers ranging from 74D1501285 through 74M1800651.
The recall affects multiple production lots manufactured between 2015 and 2019. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy.
Reason for recall: There is the potential for water to flood the column and enter the circuit under circumstances where an abnormal pressure differential is created between the water bottle and the column during high flow oxygen therapy. Distribution: nationwide Quantity: 30566 devices Lot/code info: GTIN 14026704659361 Lot Numbers: 74D1501285 74J1500185 74M1500350 74A1601241 74C1601016 74C1601472 74C1602180 74D1600257 74D1601233 74D1601232 74E1600054 74G1600014 74H1603490 74J1602886 74J1602885 74B1701597 74F1700031 74G1700590 74G1702197 74J1700026 74J1701902 74K1700026 74K1700900 74L1700541 74A1800863 74A1802331 74B1801424 74C1800022 74D1801520 74E1800781 74G1800923 74K1800769 74M1800651 74A1902597 74D1900087 74D1901071
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.