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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description Cochlear Baha Soft tissue gauge 6mm. Reusable instrument used to ensure the soft tissue thickness is equal to or less than 6 mm. For use with Baha Attract hearing system.
Recall Number Z-1699-2014
Classification Class II
Code Info Outer Package Lot COH523440, COH485876, and COH484221 with/Device Lot No. 131008
Product Distributed Qty 288
Reason For Recall Cochlear America is recalling Cochlear Baha Soft Tissue Gauge due to possible manufacturing imperfection in the smooth surface of the metal that could potentially leave residual metal on the patient's skin.

Event Detail

Event Id 68080
Product Type Devices
Status Ongoing
Recalling Firm Cochlear Americas Inc.
City Centennial
State CO
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-09
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.
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