FDA Device recall Z-1731-2014
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only
- FDA Device
- Class II
- terminated
- Published 2014-06-18
On 2014-06-18 the FDA classified a Class II recall of Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only by Summit Medical, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1731-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-12 |
| Published | 2014-06-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Summit Medical |
| Distribution | CA |
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.
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.
Identifiers
| code_info | Lot #: 147809 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1731-2014%22
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