FDAFDA · Food and drugs·Recall number Z-1731-2014
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.
Published June 18, 2014 · Recall initiated: May 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Summit Medical, Inc.
- Distributor
- Worldwide Distribution -- USA, including CA, and GERMANY.
- Lot
- Lot #: 147809
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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