CLASS II Device recall · Reported 23 Dec 2015 · FDA Enforcement Report
Hudson RCI Adult Universal Ventilator Circuit recalled
Teleflex Medical is recalling Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult, distributed in 20 states. The recall was initiated on 17 Apr 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-0419-2016
- FDA event ID
- 72731
- Recalling firm
- Teleflex Medical, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Apr 2014
- FDA classified
- 15 Dec 2015
- Reported
- 23 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 17 Apr 2014 | Recall initiated by company | |
| 15 Dec 2015 | Classified by FDA | +607 days |
| 23 Dec 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
Product as listed by the FDA
Hudson RCI Adult Universal Ventilator Circuit, Duel Heated Limb and Hudson RCI Adult Heated Wire Circuit Kit with Column
Where it was distributed
US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA.
AlabamaArizonaCaliforniaGeorgiaIllinoisKentuckyLouisianaMassachusettsMichiganMinnesotaNorth CarolinaNew JerseyNew YorkOhioOklahomaOregonPennsylvaniaTennesseeTexasWashington
Questions about this recall
Why was it recalled?
Product is being recalled due to complaints that the inspiratory and expiratory tubes are transposed.
Which lots are affected?
Lot Numbers : 02K1300128 and 02L1302324
Where was it sold?
US Distribution to the states of : AL, AZ, CA, GA, IL, KY, LA, MA, MI, MN, NJ, NY, NC, OH, OK, OR, PA, TN, TX and WA.
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.
More recalls from Teleflex Medical
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|---|---|---|---|---|---|
| Device | CLASS II | Teleflex Flex tube, Product #20011, sterile recalled by Teleflex Medical | Teleflex Medical | Other | Nationwide |
| Device | CLASS II | Gibeck Humid-Vent 2S Flex DC, Product #17731, sterile recalled | Teleflex Medical | Other | Nationwide |
| 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 |
| Device | CLASS I | Arrow-Trerotola PTD Set (Percutaneous Thrombolytic Device) recalled | Teleflex Medical | Other | Nationwide |
Other CPAP & Ventilators recalls
All 552| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (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 | Device Malfunction | Nationwide |