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U.S. Department of Health and Human Services

Enforcement Report - Week of August 28, 2013

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Event Detail

Event ID 65888
Product Type Devices
Status Ongoing
Recalling Firm Stryker Communications
City Flower Mound
State TX
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-25
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distributio: US natiowide and to the country of Canada.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Stryker Visum 300 Ceiling-mounted Exam Light. Product sold under the following part numbers: 0682001410A, 0682001410B, 0682001410C, 0682001410D, 0682001410E, 0682001410F, 0682001410G, and 0682001410H and shipped prior to February 28, 2013. Class II Potential incomplete final weld on the drop tube flange. 1,375 units Z-1992-2013