Events

Recall of Device Recall BD Integra

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
    37248
  • Event Risk Class
    Class 2
  • Event Number
    Z-0582-2007
  • Event Initiated Date
    2007-01-27
  • Event Date Posted
    2007-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50186
  • 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
    Insulin Syringe - Product Code FMF
  • Reason
    The needle becomes detached from the hub/syringe.
  • Action
    Recall notification letters were sent via UPS second day air on January 27, 2007. Distributors were asked to provide end user contact information to recalling firm.

Device

Device Recall BD Integra
  • Model / Serial
    Lot # 6073436 Ref (Reorder number) 305282)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle || 1 ml 29g 1/2'' (0.33mm x 13 mm) || Re-Order No. 305282 || U-100 insulin || Lot 6073436
  • 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