Reported Jun 18, 2014 · Terminated
Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-01, Sterilized by Ethylene Oxide, Rx Only.…
Summit Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Summit Medical, Inc. · 815 Northwest Pkwy Ste 100 · Eagan, MN · 55121-1658
Is this the product you have?
- 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.
- Lot codes and dates
- Lot #: 147809
- Amount recalled
- 9 boxes
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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