CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report
Sheridan/CF Cuffed Tracheal Tube, Sterile recalled by Teleflex Medical
Teleflex Medical is recalling Sheridan/CF Cuffed Tracheal Tube, Sterile. The recall was initiated on 12 Nov 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-0799-2015
- FDA event ID
- 69758
- Recalling firm
- Teleflex Medical, Durham, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2014
- FDA classified
- 12 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 12 Nov 2014 | Recall initiated by company | |
| 12 Dec 2014 | Classified by FDA | +30 days |
| 24 Dec 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
Product as listed by the FDA
Sheridan/CF Cuffed Tracheal Tube, Sterile, Rx only, Teleflex Medical, Research Triangle Park, NC 27708. Designed for oral and nasal intubation and are indicated for airway management.
Where it was distributed
Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
Questions about this recall
Why was it recalled?
Product Labeling; Units from the affected lot indicates that it contains a size 8mm tracheal tube but may contain a size 7.5mm tracheal tube.
Which lots are affected?
Product Code: 5-10116, Lot number: 01A1400211
Where was it sold?
Worldwide Distribution -- U.S., Belgium, Canada, and Japan.
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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