Events

Recall of Device Recall BD QSyte Luer Access Split Septum

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
    70593
  • Event Risk Class
    Class 2
  • Event Number
    Z-1317-2015
  • Event Initiated Date
    2015-02-19
  • Event Date Posted
    2015-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134096
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Becton dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum.
  • Action
    Becton Dickinson sent an Urgent Voluntary Product Recall Letter/Recall Response Card/Packing Instructions, dated 2/19/15, to their affected customers via UPS next day mail. The letters identified the affected device and explained the reason for the recall. Customers were to review their inventory for the specific catalog and lot numbers provided and quarantine the affected product. The Recall Response Card form should be completed and faxed back to BD at 1-866-514-2113 or e-mail bd7043@stericycle.com. All affected product should be returned with the completed Recall Response Card following the steps on the enclosed packing instruction. Upon receipt of the returned product, BD will send customers replacement product. If customers have questions or require assistance, they should contact 1-866-800-2917.

Device

Device Recall BD QSyte Luer Access Split Septum
  • Model / Serial
    Lot #'s 4128925 and 4128926
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of CA, CT, FL, IL, MA, ND, NY, OH and PA.
  • Product Description
    BD Q-Syte Luer Access Split Septum, 0.16 ml, Sterile, Rx only, Catalog REF #385100, Manufacturer: Becton Dickinson Infusion Therapy Systems Inc. || An accessory to an intravascular administration set that permits injection, gravity flow or withdrawal of fluids.
  • 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