Events

Recall of Progel Pleural Air Leak Sealant

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neomend 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
    63156
  • Event Risk Class
    Class 2
  • Event Number
    Z-2454-2012
  • Event Initiated Date
    2012-08-13
  • Event Date Posted
    2012-09-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112705
  • 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
    Sealant,polymerizing - Product Code NBE
  • Reason
    Product was distributed with an incorrect expiration date. product was labeled with an expiration date of 2013-04 and should have been labeled with 2012-09.
  • Action
    Neomend sent a Product Recall Notice letter dated August 13, 2012 to all affected customers. The notification letter identified the product affected, problem and actions to be taken. Customers were instructed to check their stock supply and ask the Central Supply Department to determine whether they have any unused product from the affected lot. If you do have unused units of this product follow the instructions provided. If you do not have any product with the affected lot number complete and return the enclosed TrackingVerification Form. For questions contact your Neomend sales representative.

Device

Progel Pleural Air Leak Sealant
  • Model / Serial
    Model #: PGPS002 Lot #: 111202-002
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution
  • Product Description
    Progel Pleural Air Leak Sealant, Model #: PGPS002 || Lot #: 111202-002 || Product Usage: || The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks (;::2mm) incurred during open resection of lung parenchyma.
  • Manufacturer
    Neomend Inc

Manufacturer

Neomend Inc