Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1125-2007

Laser Distance and Level Transmitters, Model No. LM200, K-Tek, Prairieville, LA 70769

K Tek / initiated 2006-11-03 / Terminated / root cause: labeling and UDI

K Tek began a recall of Laser Distance and Level Transmitters, Model No. LM200, K-Tek, Prairieville, LA 70769 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number
Z-1125-2007
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
K Tek
Product
Laser Distance and Level Transmitters, Model No. LM200, K-Tek, Prairieville, LA 70769
Product code
K--DD
Reason for recall
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)
Root cause tag
labeling and UDI
FDA root cause
Other
Action
The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.
Quantity in commerce
249 units
Distribution
Nationwide
Product codes and lots
Model No. LM200