Events

Recall of Device Recall Laser Surgical Fiber

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

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
    46251
  • Event Risk Class
    Class 2
  • Event Number
    Z-0585-2008
  • Event Initiated Date
    2007-12-18
  • Event Date Posted
    2008-04-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-04-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67039
  • 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
    Surgical Powered Laser Instrument - Product Code GEX
  • Reason
    Incorrect label: the units outer pouch is labeled 200 micro fiber however, the inner pouch's label affixed to the product indicated that it is a 365 micron fiber. the micron fiber contained in the inner pouch is 200 micro fiber. the inner product is mislabeled with the wrong size.
  • Action
    The firm notified Consignee by certified letter on 12/18/2007, and asked that all affected products be return. Any questions concerning this recall can be addressed by contacting the Manager, Regulatory Compliance, at 1-877-586-3646 ext. 3355.

Device

Device Recall Laser Surgical Fiber
  • Model / Serial
    Lot number 61280807.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    MA
  • Product Description
    Boston Scientific SlimLine 200 Micron Holmium Fiber Delivery Device, Catalog No. 840-840, Sterile, Made In Israel, Manufactured By LUMENIS, P.O.Box 240, Yokneam, ISRAEL.
  • Manufacturer
    Lumenis, Inc.

Manufacturer

Lumenis, Inc.
  • Manufacturer Address
    Lumenis, Inc., 3959 W 1820 S, Salt Lake City UT 84104-4951
  • Manufacturer Parent Company (2017)
    Laguna Holdco Ltd
  • Source
    USFDA