Teleflex Medical recalls Hudson RCI Comfort Flo Corrugated Humidification System (REF 2415) due to potential water flooding in oxygen therapy. Affected units have specific lot numbers.
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.
Teleflex Medical is recalling Hudson RCI Comfort Flo Corrugated Humidification Systems (REF 2415) because water can flood the internal circuit during high-flow oxygen therapy. This could cause electrical issues or damage to the device if water enters the circuit.
During high-flow oxygen therapy, abnormal pressure changes between the water bottle and the humidifier column can cause water to flood the internal circuit. This may lead to electrical malfunctions or device damage but does not typically cause injury.
Patients using oxygen therapy with this humidifier system are affected. Those with specific lot numbers listed in the recall are most at risk.
Check for the model number REF 2415 on the humidifier. Affected units have specific lot numbers listed in the recall notice, such as 74D1501285 or 74J1500185.
Look for the lot number on the humidifier, which should match one of the listed numbers like 74D1501285.
Reach out to Teleflex Medical for further instructions if you have the affected lot number.
The recall indicates a potential risk of water flooding during high-flow oxygen therapy, but it does not typically cause injury. The hazard is low risk.
Affected units have specific lot numbers listed in the recall, such as 74D1501285, 74J1500185, and others.
The recall does not require immediate discontinuation; however, you should check the lot number and contact Teleflex Medical for guidance.
We’ve drafted a message you can send Teleflex Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1112-2020 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1112-2020 from Teleflex Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
