Events

Recall of BD 25G Spinal Needles. (Spinal Anesthesia Needle)

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
    31657
  • Event Risk Class
    Class 2
  • Event Number
    Z-0928-05
  • Event Initiated Date
    2005-03-16
  • Event Date Posted
    2005-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38306
  • 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
    Needle, Conduction, Anesthetic (W/Wo Introducer) - Product Code BSP
  • Reason
    A significant level of 25g spinal needle hub leakage complaints was observed. subsequent investigation found the leakage to be attributable to improper formation of the spinal needle hub, specifically an undersized taper and the prescence of a slight sink in the taper surface.
  • Action
    The firm sent out notification letters on 3/16/2005.

Device

BD 25G Spinal Needles. (Spinal Anesthesia Needle)
  • Model / Serial
    Reorder Number, Lot Number: 400440, 4275101; 400440, 4282078; 400440, 4317744; 400479, 3196624; 400479, 4161815; 400479, 4254414; 400479, 4324795; 400496, 4173091; 400590, 3191978; 400590, 4121350; 400621, 4146482; 401586, 3182399; 405078, 3196618; 405078, 4169804; 405078, 4194109; 405078, 4268754; 405078, 4282079; 405078, 4324791; 405078, 4349021; 405138, 4173087; 405138, 4181398; 405140, 3224096; 405140, 4110295; 405140, 4237191; 405140, 4295872, 405140, 4314481; 405140, 4336365; 405170, 4201356; 405170, 4201357 405180, 4096782; 405180, 4145523; 405180, 4148675; 405234, 3174061; 405234, 4062807; 405234, 4105111; 405234, 4163586; 405234, 4265265; 405234, 4282715; 405234, 4282716; 405234, 4314480; 405234, 4358850; 409442, 3174062; 409442, 3226365; 409442, 4110275; 409442, 4121348; 409442, 4230810; 409442, 4230813; 409442, 4257418; 409442, 4300308; 409442, 4320423; 409442, 4329215; 409442, 4349941.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm uses distributors and ships the product directly to over 4000 hospitals and clinics nationwide.
  • Product Description
    BD 25G Spinal Needles. (Spinal Anesthesia Needle)
  • 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