Teleflex Medical Recalls Hudson RCI Comfort Flo Humidifier Nebulizer Kits
Teleflex Medical is recalling 30,566 Hudson RCI Comfort Flo humidifier nebulizer kits because water may flood the column and enter the circuit during high-flow oxygen therapy.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "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."
Plain-English summary
Teleflex Medical Inc. is recalling 30,566 units of the Hudson RCI Comfort Flo Corrugated Humidification System, Reference 2415, humidifier nebulizer kit. The devices were distributed nationwide.
The recall is due to a potential safety hazard where water may flood the column and enter the circuit. This can occur under circumstances where an abnormal pressure differential is created between the water bottle and the column during high-flow oxygen therapy.
The affected devices are identified by GTIN 14026704659361 and specific lot numbers listed in the official recall notice. Consumers and healthcare providers should stop using the affected devices and contact Teleflex Medical for instructions on return or replacement.
The recalled product
- Product
- HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
- Manufacturer
- TELEFLEX MEDICAL INC
- Affected units
- 30,566
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by TELEFLEX MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · TELEFLEX MEDICAL INC
See all →- HighTeleflex Breathing Tubes Recalled Due to Reports of Tearing
FDA (Devices) · 2022-06-01
- HighGibeck Humid-Vent Breathing Filters Recalled for Torn Corrugated Tubes
FDA (Devices) · 2022-06-01
- SevereTeleflex Arrow-Trerotola Percutaneous Thrombolytic Device PTD Kit recalled for tip separation
FDA (Devices) · 2022-02-23
- SevereArrow-Trerotola Dialysis Catheter Recalled for Tip Separation During Use
FDA (Devices) · 2022-02-23
- SevereArrow-Trerotola Thrombolytic Catheter Kits Recalled for Tip Separation During Use
FDA (Devices) · 2022-02-23
Same hazard · water ingestion
See all →- SevereTeleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
FDA (Devices) · 2020-02-19
- SevereVyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk
FDA (Devices) · 2018-01-31
- SevereVyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk
FDA (Devices) · 2018-01-31
Similar recalls
- ModerateTeleflex Recalls Hudson RCI Breathing Circuits Due to Temperature Probe Defect
FDA (Devices) · 2014-07-30
- ModerateTeleflex Recalls Hudson RCI Humidifier Adaptors Due to Foreign Material
FDA (Devices) · 2015-02-18
- ModerateTeleflex Medical Recalls Hudson RCI ConchaTherm Neptune Heated Humidifiers
FDA (Devices) · 2015-05-06
- HighTeleflex Medical Recalls Hudson RCI Concha Therm Neptune Humidifiers
FDA (Devices) · 2012-07-25
- CriticalTeleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes
FDA (Devices) · 2015-02-18
- HighTeleflex Medical Recalls Hudson RCI Adult Universal Ventilator Circuits
FDA (Devices) · 2015-12-23