CLASS II Device recall · Reported 15 Feb 2017 · FDA Enforcement Report
Sheridan/CF, Cuffed Tracheal Tube recalled by Teleflex Medical
Teleflex Medical is recalling Sheridan/CF, Cuffed Tracheal Tube, distributed in 37 states. The recall was initiated on 18 Oct 2016 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-1177-2017
- FDA event ID
- 76133
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Oct 2016
- FDA classified
- 9 Feb 2017
- Reported
- 15 Feb 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 18 Oct 2016 | Recall initiated by company | |
| 9 Feb 2017 | Classified by FDA | +114 days |
| 15 Feb 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
Product as listed by the FDA
Sheridan/CF, Cuffed Tracheal Tube, Catalog # 5-10114 and Sheridan/HVT Cuffed Tracheal Tube, Catalog # 5-10315 A tracheal tube is inserted into a patients mouth or nose for airway management
Where it was distributed
Worldwide Distribution - US including AL, AZ, ARK, CA, CO, CT, FL, GA. HI, KS, KY, IL, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV and Internationally to Canada, Chile, & Japan
AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Why was it recalled?
Labeling inconsistency - units labeled with a 7mm tube may contain a size 6.5mm tube, and units labeled 7.5mm tube may contain a size 5.5mm tube.
Which lots are affected?
Lots 73A1500461 & 73D1400082
Where was it sold?
Worldwide Distribution - US including AL, AZ, ARK, CA, CO, CT, FL, GA. HI, KS, KY, IL, IN, IA, LA, MD, MA, MI, MN, MS, MO, MT, NE, NJ, NM, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV and Internationally to Canada, Chile, & 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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