Events

Recall of PolypVac

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Laurimed 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
    67950
  • Event Risk Class
    Class 3
  • Event Number
    Z-1527-2014
  • Event Initiated Date
    2014-04-07
  • Event Date Posted
    2014-04-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126647
  • 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
    Drill, surgical, ent (electric or pneumatic) including handpiece - Product Code ERL
  • Reason
    The reciprocation mechanism in the polypvac microdebrider may turn off prematurely due to a component failure in the device handle.
  • Action
    All direct accounts were notified on April 8, 2014 with an Urgent: Medical Device Recall of PolypVac Microdebrider letter, sent by first class mail. The letter identified the affected product, the reason for the recall, and stated that the firm is in the process of implementing corrections. The firm is requesting that all unused lots be returned to them. Replacement devices will sent to customers. In addition, customers are to complete the attached Lot Information sheet. Questions should be directed to bdubois@laurimed.com or 650-587-5296.

Device

PolypVac
  • Model / Serial
    Lot Number: LFG-111813-1; Expiry date: June 2014; LFG020614-01, Expiry date: September 2014.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of CA, VT, NC, DO, TX, FL, PA, OR, AZ, IL, ID, and VA.
  • Product Description
    PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebrider, 1 Stylet, 1 filter. Sterile. Used for the excision of polyps in the nasal passageways and in sinuses for which access has been previously established.
  • Manufacturer
    Laurimed LLC

Manufacturer

Laurimed LLC
  • Manufacturer Address
    Laurimed LLC, 500 Arguello St, Redwood City CA 94063-1566
  • Manufacturer Parent Company (2017)
    Laurimed Llc
  • Source
    USFDA