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U.S. Department of Health and Human Services

Class 2 Device Recall Laser Distance and Level Transmitters

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  Class 2 Device Recall Laser Distance and Level Transmitters see related information
Date Initiated by Firm November 03, 2006
Date Posted September 25, 2007
Recall Status1 Terminated 3 on December 10, 2008
Recall Number Z-1121-2007
Recall Event ID 44899
Product Classification Laser Distance and Level Transmitters - Product Code K--DD
Product Laser Level Transmitters, Model No. LM4C, K-TEK, 18321 Swamp Road, Prairieville, LA 70769
Code Information Model No. LM4C
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 2		 Other
Action The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.
Quantity in Commerce 129 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.
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