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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of harm (water entering the circuit) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
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 →- HighTeleflex Medical Recalls Hudson RCI Comfort Flo Humidification Systems
FDA (Devices) · 2020-02-19
- HighVyaire Medical Recalls AirLife Humidification Chambers Due to Overflow Risk
FDA (Devices) · 2018-01-31
- HighVyaire Medical Recalls Infant AirLife Humidification Chambers Due to Overflow Risk
FDA (Devices) · 2018-01-31