Teleflex Medical recalls Hudson RCI Comfort Flo Corrugated Humidification Systems with Remote Temperature Port (REF 2416) due to potential water flooding and circuit entry during high flow 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 humidification systems with remote temperature ports because water could flood the internal circuit during high flow oxygen therapy. This could lead to equipment malfunction or injury if not addressed.
During high flow oxygen therapy, abnormal pressure changes between the water bottle and humidification column could cause water to flood the internal circuit. This might lead to equipment malfunction or potential injury if the system fails during use.
Patients using oxygen therapy with the recalled humidification systems are most at risk. The recall affects specific model numbers and lot numbers sold between 2014 and 2019.
Check for the model name 'Hudson RCI Comfort Flo Corrugated Humidification System with Remote Temperature Port' and lot numbers listed in the recall notice. The product has a specific reference number (REF 2416).
Identify the lot number on your humidifier to confirm if it's affected by this recall.
Reach out to Teleflex Medical for guidance on next steps if your unit is affected.
The recall is due to potential water flooding the internal circuit during high flow oxygen therapy, which could cause equipment malfunction or injury.
Check the lot number on your unit; if it matches the listed numbers, contact Teleflex Medical for instructions.
The recall record does not specify a remedy, so contact Teleflex Medical directly 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-1113-2020 — Teleflex Medical Teleflex Medical Hello, I own a Teleflex Medical that is covered by recall Z-1113-2020 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.
