Recall Z-0414-2013— Kerr Corporation
Class II · Terminated
Class II FDA medical device recall by Kerr Corporation, initiated 2012-04-10, terminated 2012-11-21. FDA's recall record names no specific 510(k) clearance for this event. Product: The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.. Reason: The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device..
- Recalling firm
- Kerr Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-04-10
- Terminated
- 2012-11-21
- Firm location
- Middleton, WI, United States
Product description
The brand name of the device is Laser Loupes, a dentalloupe with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. Laser Loupes are available with four (4) different filters of different colors. Each colored filter is associated with specific laser frequency ranges. The device listing number for this product is E160359. The intended use of this device is to magnify the operatory field and provide laser eye protection.
Reason for recall
The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device.
Data sourced from openFDA. This site is unofficial and independent of the FDA.