Device recall: HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit
Class I FDA enforcement event 84588. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
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
TELEFLEX MEDICAL INC started this device recall on 13 Dec 2019. The firm address in the FDA record is in Morrisville, NC. FDA put the recall in Class I. FDA event 84588 has 4 product records. The first FDA enforcement report date is 19 Feb 2020. The record gives the status Terminated, with the termination date 30 Apr 2024.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
nationwide
Recalling firm
TELEFLEX MEDICAL INC, Morrisville, NC.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
4 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1112-2020 | HUDSON RCI COMFORT FLO Corrugated Humidification System, REF 2415, humidifier nebulizer kit | 30566 devices | Class I | Terminated | 19 Feb 2020 |
| Z-1113-2020 | HUDSON RCI COMFORT FLO Corrugated Humidification System with Remote Temperature Port, REF 2416, humidifier nebulizer kit | 60467 devices | Class I | Terminated | 19 Feb 2020 |
| Z-1114-2020 | HUDSON RCI COMFORT FLO Humidification System, REF 2410, humidifier nebulizer kit | 127293 devices | Class I | Terminated | 19 Feb 2020 |
| Z-1115-2020 | HUDSON RCI COMFORT FLO Humidification System With Remote Temperature Port, REF 2414, humidifier nebulizer kit | 95696 devices | Class I | Terminated | 19 Feb 2020 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2019
- 968
- Share of these events in Class I
- 6%
- Product records in this event
- 4Median of the firm: 2
- Events of the firm on the register
- 12
Other events of the firm
Official channels
- FDA enforcement report Z-1112-2020The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 84588. https://recallregister.com/fda/i/84588/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
nationwide
- What quantity of product is in FDA event 84588?
- The event has 4 product records. The first record gives this quantity:
30566 devices
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2019 have the same class?
- 6% of the 968 device events that started in 2019 are in Class I.