Class 2 Device Recall DBLF602 Bare Laser fiber

• Date Initiated by Firm: June 20, 2014
• Date Posted: July 17, 2014
• Recall Status: Terminated 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: 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