Events

Recall of BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

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
    33965
  • Event Risk Class
    Class 3
  • Event Number
    Z-0152-06
  • Event Initiated Date
    2005-06-30
  • Event Date Posted
    2005-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42826
  • 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
    Blade, Scalpel - Product Code GES
  • Reason
    Bd received reports of unit packages labeled with the incorrect blade edge. the incorrectly labeled unit packages indicate a '12' (single edged blade) is present, the actual blade present is a '12b' (double edged blade).
  • Action
    A urgent product recall was sent to distributors on 6/30/2005 by first class mail. End users were then identified and recall notifications were also sent to them. by first class mail.

Device

BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use
  • Model / Serial
    Lot # 4174460, Reorder # 371712
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Product was distributed to 9 distributors nationwide and then to end users.
  • Product Description
    BD Bard-Parker Special Surgeon''s Peridontia Blade, Sterile, Single Use
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA