Events

Recall of BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''.

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
    32005
  • Event Risk Class
    Class 3
  • Event Number
    Z-1075-05
  • Event Initiated Date
    2005-04-19
  • Event Date Posted
    2005-08-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-10-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38901
  • 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
    A small percentage of scalpels exhibited a 'double blade' condition.
  • Action
    Letters were sent to all customers and all customers have also been contacted by phone. Letters were sent on 4/49/2005.

Device

BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''.
  • Model / Serial
    Lot Number 4322604.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The scalpels were distributed to kit manufacturers. These include: Cardinal Health, 1300 Waukegan Road, McGaw Park, Il 60085; Bard Health Care, 201 West Anaya Road, Hidalgo, TX 78577; Edwards Lifesciences, 6864 South 300 West, Salt Lake City, UT 84047; Avid Medical, 900 Westmount Dr., James City, VA 23168; DeRoyal Industries, PO Box 1667, Knoxville, TN 37849; Boston Scientific, 780 Brookside Dr., Owen, IN 47460; Medikmark, 3600 Burwood Dr., Waukegan Lake, IL 60085; CustoMed/Puerto Rico Hospital Supply, Carolina, PR 00987.
  • Product Description
    BD #11 Bard Parker Scalpel. A general use surgical blade, frequently used for ''stab incisions''. A non sterile, disposable, stainless steel blade. Reorder Number 371631.
  • 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