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Terminated

Laser Level Transmitters, Model No. LM4C, K-TEK, 18321 Swamp Road, Prairieville, LA 70769

FDA Recall Z-1121-2007 · Posted 2007-09-25

Recalling FirmK Tek
Recall StatusTerminated
Product CodeK--DD
Date Initiated2006-11-03
Date Terminated2008-12-10
Product Quantity129 units

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)

Firm Action

The firm notified its consignee of problem and the field correction by letter dated 11/03/2006.

Root Cause

Other

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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