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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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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
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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Product Code: NCL-L-CD15; Lot Numbers and Expiration Dates: 6017936, Expires 2014-08; 6015073, Expires 2014-03 Class II 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. 145 units Z-1710-2014