Enforcement Report - Week of November 28, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0402-2013 |
| Classification | Class II |
| Code Info | 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. |
| Product Distributed Qty | 1330 units |
| Reason For Recall | 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. |
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. |
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