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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Event Detail

Event ID 68267
Product Type Devices
Status Completed
Recalling Firm Summit Medical, Inc.
City Eagan
State MN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-12
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution -- USA, including CA, and country of: GERMANY.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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 #: 147809 Class II 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. 9 boxes Z-1731-2014
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