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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description 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.
Recall Number Z-1731-2014
Classification Class II
Code Info Lot #: 147809
Product Distributed Qty 9 boxes
Reason For Recall 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.

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.
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