Device product
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.
Z-1938-2016
Product summary
- Firm
- Teleflex Medical
- Event
- Event 74034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,390 ea.
- Official record key
device-enforcement:Z-1938-2016
Official wording
Reason: The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.
Code information: Lot 73F1500606
Distribution pattern: 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.
Derived failure modes
-
Unknown
The labeling of some units indicates that it contains a size 7mm tracheal tube, but may contain a size 7.5mm tracheal tube.