FDA Recall
Terminated
Laser Meter, Model No. LTM80, K-TEK, Prairieville, LA 70769
Recall: Z-1123-2007
·
Initiated November 3, 2006
Recall
- Recall Number
- Z-1123-2007
- 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 Meter, Model No. LTM80, K-TEK, Prairieville, LA 70769
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
268 units