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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-1710-2014
Classification Class II
Code Info Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03
Product Distributed Qty 145 units
Reason For Recall Product does not function as intended up to the expiry date on the product labeling. There is a link between the age of the product and staining intensity.

Event Detail

Event Id 68090
Product Type Devices
Status Ongoing
Recalling Firm Leica Microsystems, Inc.
City Buffalo Grove
State IL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-01-10
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - US Nationwide in the states of CA, CT FL, IL, MO, MS, NC, NY, PA, and the countries of Argentina, Australia, Brazil, Colombia, Italy, Malaysia, New Zealand, Nigeria, Poland, Romania, Russia, Saudi Arabia, Serbia, South Africa, Sweden, Taiwan, Tunisia, Turkey, and United Kingdom