Events

Recall of PROLENE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by McKesson General Medical Corporation.

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
    27682
  • Event Risk Class
    Class 2
  • Event Number
    Z-0249-04
  • Event Initiated Date
    2003-10-31
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30331
  • 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
    Counterfeit product is an unapproved medical device with associated potential health hazard.
  • Action
    The distributor notified all distribution centers and field personnel by e-mail on 10/29/03. The firm''s centers were instructed to inspect and quarantine lots RBE609 and RJJ130. Field personnel were instructed to notify customers to quarantine counterfeit product and any suspect product. On 10/30/03, the recalling distributor notified its field representatives to inspect and quarantine all lots of the mesh. The firm issued a recall notification with reply form to all consignees receiving surgical mesh product since Jan 03.

Device

PROLENE
  • Model / Serial
    All codes, including the lots that the manufacturer of authentic product specified as counterfeit, RBE609 EXP1/07 and RJJ130 EXP 7/07.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US.
  • Product Description
    PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton
  • Manufacturer
    McKesson General Medical Corporation

Manufacturer

McKesson General Medical Corporation
  • Manufacturer Address
    McKesson General Medical Corporation, 5601 Eastport Boulevard, Richmond VA 23231
  • Source
    USFDA