Events

Recall of Device Recall Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip

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
    59469
  • Event Risk Class
    Class 2
  • Event Number
    Z-3086-2011
  • Event Initiated Date
    2011-07-18
  • Event Date Posted
    2011-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102847
  • 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
    Mislabeled: renew product number 3262 (long fenestrated grasper) was packaged and labeled as product number 3642 (super-atrau fenestrated grasper). renew product number 3642 (super-atraumatic fenestrated grasper) was packaged and labeled as 3262 (long fenestrated grasper.
  • Action
    Microline Surgical sent a RECALL NOTICE letter dated July 18, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine product subject to the recall. If customers further distributed the product, customers should identify their accounts and notify them immediately of the product recall. Customers were instructed to contact Microline Customer Service to obtain a Return Authorization Number for return of the recalled item. Customers were asked to complete and return the enclosed Recall Return Response Form as soon as possible. For any questions customers were instructed to call the Regulatory Affairs Manager at 978-867-1726.

Device

Device Recall Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper For...
  • Model / Serial
    Lot Number: 00105709 Expiration date: 5-2016
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including FL, MI, MN, TN and WI and the countried of Canada, The Netherlands, Thailand, UK, Norway, and Italy.
  • Product Description
    Microline Surgical ReNew Laproscopic ControlTip Atraumatic Fenestrated Grasper Forceps Tip || Ref: 3642 || The ReNew Forceps Laparoscopic Surgical Tips are intended to cut, grasp and dissect various abdominal tissue for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula
  • 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