Events

Recall of Device Recall BD

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
    75802
  • Event Risk Class
    Class 2
  • Event Number
    Z-0740-2017
  • Event Initiated Date
    2016-11-07
  • Event Date Posted
    2016-12-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151303
  • 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
    Spinal epidural anesthesia kit - Product Code OFT
  • Reason
    Bd is conducting a voluntary product recall of the bd spinal anesthesia tray, cat (ref) 405671, lot b01k089d since a very low number of trays are incorrectly labeled as bd single shot epidural tray, cat (ref) 406069.
  • Action
    BD sent an Urgent Product Recall letter dated November 7, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to immediately review their inventory for the affected product. Return the affected products with the Business Response Card form following the instruction on the enclosed packing instruction. The completed form should be faxed to 1-866-240-5212 or email the completed form to bd6549@stericycle.com. Customers with questions were instructed to call 1-866-792-5451. For questions regarding this recall call 866-792-5451.

Device

Device Recall BD
  • Model / Serial
    B01K089D
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Spinal Anesthesia Tray || The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure
  • 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