Events

Recall of Device Recall DBLF602 Bare Laser fiber

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Laser Peripherals LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68674
  • Event Risk Class
    Class 2
  • Event Number
    Z-2073-2014
  • Event Initiated Date
    2014-06-20
  • Event Date Posted
    2014-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128432
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • Reason
    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'.
  • 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.

Device

Device Recall DBLF602 Bare Laser fiber
  • Model / Serial
    E14128 & E14129
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to IL, IN, and MD
  • Product Description
    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
  • Manufacturer
    Laser Peripherals LLC

Manufacturer

Laser Peripherals LLC
  • Manufacturer Address
    Laser Peripherals LLC, 13355 10th Ave N, Suite 110, Plymouth MN 55441-5553
  • Manufacturer Parent Company (2017)
    Laser Peripherals Llc
  • Source
    USFDA