FDA Recall
Terminated
Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117, Houston, TX 77024
Recall: Z-1120-2007
·
Initiated November 3, 2006
Recall
- Recall Number
- Z-1120-2007
- Event Number
- 44899
- Firm
- K Tek
- FEI Number
- 3003115967
- Product Code
- K--DD
- Status
- Terminated
- Root Cause
- Other
- Initiated
- November 3, 2006
- Posted
- September 25, 2007
- Terminated
- December 10, 2008
- Address
- 18321 Swamp Rd, Galvez, LA, 70769-3335
Description
Laser Distance and Level Transmitters, Model No. LT4C, ASI, 8570 Katy Freeway, Suite 117, Houston, TX 77024
Reason
Failure to comply with Federal Laser Product Performance Standards (21 CFR 1040.10, 1040.11, 1002.10-improper classification, incomplete labeling, incomplete user information and failure to submit required product reports)
Action
The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.
Distribution
Nationwide
Quantity
1 unit