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U.S. Department of Health and Human Services

Class 2 Device Recall CTC laser sights

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  Class 2 Device Recall CTC laser sights see related information
Date Initiated by Firm October 10, 2017
Date Posted April 23, 2018
Recall Status1 Open3, Classified
Recall Number Z-1361-2018
Recall Event ID 79669
Product Classification Laser aiming product, visible - Product Code REU
Product Crimson Trace Corporation laser sights.

The Finished Products are laser sighting systems for firearms, used for personal defense and target acquisition.
Code Information Model No. CTC with Laser Sights.  
Recalling Firm/
Manufacturer
Crimson Trace Corporation
9780 Sw Freeman Dr
Wilsonville OR 97070-9221
For Additional Information Contact
800-442-2406
Manufacturer Reason
for Recall
A previously "in specification" Finished Product with a Model 25-0657 diode had power output higher than 5 mW.
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Crimson Trace Corporation (CTC) will bring defect into compliance: 1.CTC will send notification letters or emails to all relevant dealers, distributors, and purchasers, 2.CTC will provide return merchandise authorization numbers and shipping labels to all relevant dealers, distributors, and purchasers, 3.CTC will replace all returned product units with compliant diodes, 4.The corrections will be conducted at no cost to the purchaser, and 5.The corrective action will be completed by January 31, 2019. For further questions, please call (800) 442-2406.
Quantity in Commerce 184,390
Distribution USA (nationwide) Distribution
Total Product Life Cycle TPLC Device Report

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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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