Events

Recall of Device Recall Composix L/P with Echo PS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Davol, Inc., Subs. C. R. Bard, 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
    67149
  • Event Risk Class
    Class 2
  • Event Number
    Z-0820-2014
  • Event Initiated Date
    2014-01-03
  • Event Date Posted
    2014-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124782
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Reason
    Product labeling does not match product configuration.
  • Action
    Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via fax to 401-825-8753. For questions regarding this recall call 800-556-6275,

Device

Device Recall Composix L/P with Echo PS
  • Model / Serial
    Lot# HUXG0491, HUXH0295
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
  • Product Description
    Composix L/P with Echo PS 6" X 8" Product Code 0144680 || The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
  • Manufacturer
    Davol, Inc., Subs. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Subs. C. R. Bard, Inc.
  • Manufacturer Address
    Davol, Inc., Subs. C. R. Bard, Inc., 100 Crossings Blvd, Warwick RI 02886-2850
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA