Recall Z-0402-2013— Kerr Corporation
Class II · Terminated
Class II FDA medical device recall by Kerr Corporation, initiated 2011-11-17, terminated 2012-11-20. FDA's recall record names no specific 510(k) clearance for this event. Product: 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.. Reason: 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..
- Recalling firm
- Kerr Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-11-17
- Terminated
- 2012-11-20
- Firm location
- Middleton, WI, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.