Class 2 Device Recall Laser Level Transmitters

• Date Initiated by Firm: November 03, 2006
• Date Posted: September 25, 2007
• Recall Status: Terminated on December 10, 2008
• Recall Number: Z-1124-2007
• Recall Event ID: 44899
• Product Classification: Laser Distance and Level Transmitters - Product Code K--DD
• Product: Laser Distance and Level Transmitters, Model No. LT200, ASI, Housotn, TX 77024
• Code Information: Model No. LT200
• Recalling Firm/ Manufacturer: K Tek; 18321 Swamp Rd; Galvez LA 70769-3335
• For Additional Information Contact: Rao Sanampudi; 225-673-6100
• Manufacturer 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)
• FDA Determined Cause: Other
• Action: The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.
• Quantity in Commerce: 21 units
• Distribution: Nationwide

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.