HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
Reported: February 19, 2020 Initiated: December 13, 2019 #Z-1112-2020
Product Description
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
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.
Details
- Recalling Firm
- TELEFLEX MEDICAL INC
- Units Affected
- 30566 devices
- Distribution
- nationwide
- Location
- Morrisville, NC
Frequently Asked Questions
What product was recalled? ▼
HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit. Recalled by TELEFLEX MEDICAL INC. Units affected: 30566 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 19, 2020. Severity: Critical. Recall number: Z-1112-2020.
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