CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report
Hudson Rci¿ Humidifier Adaptor, 040 contained recalled
Teleflex Medical is recalling Hudson Rci¿ Humidifier Adaptor, 040 contained in the following units: Humidifier Adaptor, distributed nationwide in the US. The recall was initiated on 14 Jan 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1095-2015
- FDA event ID
- 70280
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2015
- FDA classified
- 11 Feb 2015
- Reported
- 18 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Device type
- Other Medical Devices
Timeline
| 14 Jan 2015 | Recall initiated by company | |
| 11 Feb 2015 | Classified by FDA | +28 days |
| 18 Feb 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The packages may contain foreign material (black particles).
Product as listed by the FDA
Hudson RCI¿ Humidifier Adaptor, 040 contained in the following units: HUMIDIFIER ADAPTOR 040 Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.
Where it was distributed
Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
Questions about this recall
Why was it recalled?
The packages may contain foreign material (black particles).
Which lots are affected?
Product Code: 000-40, Lot numbers: BE08, BG05 BG08, BM18, CB11 & CB17.
Where was it sold?
Worldwide Distribution - U.S. Nationwide and the countries of: Australia, Bahrain, Belgium, Bermuda, Brazil, Canada, China, Ecuador, Germany, Great Britain, Hong Kong, Indonesia, Japan, Jordan, Malaysia, Mexico, New Zealand, Philippines, Singapore, South Korea, Saudi Arabia, Taiwan, Thailand, Uruguay and Zambia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 70280This product is part of a recall event; the main page for the event is Aquapak 640 Sw W/040 Adaptor, Intl recalled by Teleflex Medical.
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