CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed recalled
Teleflex Medical is recalling Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, distributed in 12 states. The recall was initiated on 9 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-1078-2015
- FDA event ID
- 70248
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Jan 2015
- FDA classified
- 10 Feb 2015
- Reported
- 18 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 9 Jan 2015 | Recall initiated by company | |
| 10 Feb 2015 | Classified by FDA | +32 days |
| 18 Feb 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
Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
Product as listed by the FDA
Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only, Sterile, Teleflex Medical.
Where it was distributed
Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
FloridaGeorgiaIllinoisKentuckyMassachusettsMichiganMissouriMississippiOhioTexasWashingtonWest Virginia
Questions about this recall
Why was it recalled?
Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; The correct product labeling is uncuffed nasal ET tube.
Which lots are affected?
Catalog no. 5-22110, Lot no. 01M1300076.
Where was it sold?
Worldwide Distribution - US Distribution to the states of FL, GA, IL, KY, MA, MI, MO, MS, OH, TX, WA and WV., and to the countries of Canada and the Netherlands.
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.
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