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Summit Medical, Inc. recalls Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only.
Recalled June 18, 2014 · FDA recall Z-1731-2014 · Summit Medical
Hazard
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. · FDA Class II
Units
9 boxes
Sold at
Worldwide Distribution -- USA, including CA, and GERMANY.
Description
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.
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.
Manufacturer(s)
Summit Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →