CLASS II Device recall · Reported 30 Jul 2014 · FDA Enforcement Report
Hudson RCI, Breathing Circuit, Adult Single Limb recalled
Teleflex Medical is recalling Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), distributed in 16 states. The recall was initiated on 9 Jul 2014 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-2108-2014
- FDA event ID
- 68731
- Recalling firm
- Teleflex Medical, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jul 2014
- FDA classified
- 23 Jul 2014
- Reported
- 30 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Temperature Abuse
- Device type
- CPAP & Ventilators
Timeline
| 9 Jul 2014 | Recall initiated by company | |
| 23 Jul 2014 | Classified by FDA | +14 days |
| 30 Jul 2014 | 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 temperature probe does not properly connect to the temperature port.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier.
Where it was distributed
Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines
CaliforniaFloridaKansasKentuckyMassachusettsMichiganMissouriNorth CarolinaNebraskaNew JerseyNew YorkOhioPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Is Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece) recalled?
Yes. Teleflex Medical recalled Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece) on 9 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2108-2014.
Why was it recalled?
The temperature probe does not properly connect to the temperature port.
Which lots are affected?
Catalog Number: 1696, Lot numbers: 02K1301986, 02L1300010, 02L1300037, 02L1301081, 02L1301783, 02M1300190, 02M1300236, 02A1400518 02A1401286, 02A1402358, 02B1400178, 02B1400715 & 02B1401320.
Where was it sold?
Worldwide Distribution - US including the states of CA, FL, KS, KY, MA, MI, MO, NC, NE, NJ, NY, OH, PA, TN, TX and VA, and the countries of Argentina, Chile, Colombia, and the Philippines
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS I | Arrow-Trerotola Over-The-Wire PTD Kit recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
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Other CPAP & Ventilators recalls
All 551| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo-n recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |
| Device | CLASS I | Astral 100/150 Resmed Astral 100/50 is a ventilator system recalled | ResMed | Packaging Defects | Nationwide |
| Device | CLASS I | Breathing circuit set, coaxial recalled by Hamilton Medical AG | Hamilton Medical AG | Device Malfunction | Nationwide |
| Device | CLASS I | Giraffe Stand-alone Infant Resuscitation System recalled by Datex-Ohmeda | Datex-Ohmeda | Device Malfunction | WI |