Device product
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only. Intended to provide ventilation to the middle ear space through the tympanic membrane.
Z-1731-2014
Product summary
- Event
- Event 68267
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 boxes
- Official record key
device-enforcement:Z-1731-2014
Official wording
Reason: One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
Code information: Lot #: 147809
Distribution pattern: Worldwide Distribution -- USA, including CA, and GERMANY.
Derived failure modes
-
Unknown
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.