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U.S. Department of Health and Human Services

Class 2 Device Recall DBLF602 Bare Laser fiber

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  Class 2 Device Recall DBLF602 Bare Laser fiber see related information
Date Initiated by Firm June 20, 2014
Date Posted July 17, 2014
Recall Status1 Terminated 3 on October 22, 2014
Recall Number Z-2073-2014
Recall Event ID 68674
510(K)Number K030959  
Product Classification Powered laser surgical instrument - Product Code GEX
Product LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO.

Laser surgical instrument for use in general and plastic surgery and in dermatology
Code Information E14128 & E14129
Recalling Firm/
Manufacturer		 Laser Peripherals LLC
13355 10th Ave N
Suite 110
Plymouth MN 55441-5553
For Additional Information Contact
763-525-8460
Manufacturer Reason
for Recall		 Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as '2016-16' as opposed to the intended date of '2016-06'.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Laser Peripherals contacted all consignees via telephone on June 20, 2014, in regard to the product being recalled by following the firm's Standard Operating Procedures. The SOP's included Instructions to immediately stop the use of the recalled product and provided other communications related to the recall. For questions regarding this recall call 612-280-1318.
Quantity in Commerce 25
Distribution Nationwide Distribution to IL, IN, and MD
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = LASER PERIPHERALS LLC.
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