Events

Recall of Device Recall Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Microline Surgical, 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
    68495
  • Event Risk Class
    Class 2
  • Event Number
    Z-1986-2014
  • Event Initiated Date
    2014-05-12
  • Event Date Posted
    2014-07-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128076
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Potential for the fenestrated grasper tip jaw to break when force is applied to the jaw.
  • Action
    Microline Surgical notified Distributors, Hospitals (Customers/End Users) and Suppliers via letter dated May 15, 2014 with labeling, pictures, and Recall Response Forms via UPS Overnight Air, email, and/or fax. Product is requested to be returned and a RMA number will be issued. Contact 978-867-1775 for questions.

Device

Device Recall Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips
  • Model / Serial
    Lot Numbers: 00115342
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA including the states of CA, HI, ID, MA, MI, MS, PA, TN, UT, and TX. and the countries of Belgium, France, Ireland, Germany, Indonesia, Korea, Norway, Saudi Arabia, Switzerland, Turkey, and UK.
  • Product Description
    Microline Surgical ReNew Laproscopic Fenestrated Grasper Forceps Tips || Ref 3221
  • Manufacturer
    Microline Surgical, Inc.

Manufacturer

Microline Surgical, Inc.
  • Manufacturer Address
    Microline Surgical, Inc., 800 Cummings Ctr Ste 166t, Beverly MA 01915-6171
  • Manufacturer Parent Company (2017)
    HOYA Corp.
  • Source
    USFDA