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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 sightssee related information
Date Initiated by FirmOctober 10, 2017
Date PostedApril 23, 2018
Recall Status1 Terminated 3 on November 22, 2019
Recall NumberZ-1361-2018
Recall Event ID 79669
Product Classification Laser aiming product, visible - Product Code REU
ProductCrimson 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
ActionCrimson 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 Commerce184,390
DistributionUSA (nationwide) Distribution
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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