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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63512
Product Type Devices
Status Terminated
Recalling Firm Kerr Corporation
City Middleton
State WI
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-11-17
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) and the countries of Canada, Australia, and Europe.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Freedom Cordless LED Light System. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System is a Class I Medical Device. The device listing number this product is E115952. The intended use of this device is to illuminate oral structures and operating areas. Freedom System, Standard Length, Part Number 910863-1, Serial Numbers 77001000-77003470 and Freedom System, Long Length, Part Number 910863-2, Serial Numbers 77001000-77003470. Freedom Cordless LED Light System has no expiration date. The affected units were produced and distributed since February 2011. Class II The firm recalled the Freedom Cordless LED Headlight because some units were assembled with an incorrect component in the control board electronics that may cause some Freedom Cordless LED Headlight units to become warm to the touch; however, no skin damage will occur. 1330 units Z-0402-2013
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