Events

Recall of Bard Ventralight ST Mesh

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
    63069
  • Event Risk Class
    Class 2
  • Event Number
    Z-2412-2012
  • Event Initiated Date
    2012-09-04
  • Event Date Posted
    2012-09-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112452
  • 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
    Mislabeled: the 8" x 10" package contains 7" x 9" ventralight st mesh product and the 7" x 9" package contains 8" x 10" ventralight st mesh product.
  • Action
    Davol issued an "URGENT: MEDICAL DEVICE RECALL" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter advises customers to examine their inventory and quarantine affected product for return to the firm. Customers were asked to complete and return a Recall Effectiveness Check Form. Contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027 if you have any questions.

Device

Bard Ventralight ST Mesh
  • Model / Serial
    Lot # HUWE1779
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Bard Ventralight ST Mesh. - Ellipse 8" x 10" (20.3 cm x 25.4 cm) || Product Code 5954810. || The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
  • 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