Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-2073-2014 · Posted 2014-07-17

Recalling FirmLaser Peripherals LLC
Recall StatusTerminated
Product CodeGEX
Date Initiated2014-06-20
Date Terminated2014-10-22
Product Quantity25

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'.

Firm 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.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution to IL, IN, and MD

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100Laser Peripherals, LLC · 2003-04-25

Official Source

View FDA Recall →

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

↑