CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube recalled
Teleflex Medical is recalling Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, distributed in 23 states. The recall was initiated on 5 May 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-1938-2016
- FDA event ID
- 74034
- Recalling firm
- Teleflex Medical, Research Triangle Park, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 May 2016
- FDA classified
- 9 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 May 2016 | Recall initiated by company | |
| 9 Jun 2016 | Classified by FDA | +35 days |
| 15 Jun 2016 | 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
The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
Product as listed by the FDA
Sterile Sheridan/HVT Cuffed, Murphy Eye, Tracheal Tube, Ref: V5-10314, ID: 7.0 mm, Rx Only, Manufactured by: Teleflex Incorporated. A tracheal tube is inserted into a patients mouth or nose for airway management.
Where it was distributed
US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.
AlabamaArizonaColoradoFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNew YorkOklahomaPennsylvania
Questions about this recall
Why was it recalled?
The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
Which lots are affected?
Lot 73F1500606
Where was it sold?
US Distribution to states of: AL, AZ, CO, FL, GA, ID, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NY, NC, OK, PA, RI, TX and UT.
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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