Events

Recall of Device Recall BD Beaver

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson and 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
    37057
  • Event Risk Class
    Class 2
  • Event Number
    Z-0402-2007
  • Event Initiated Date
    2006-12-26
  • Event Date Posted
    2007-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49826
  • 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
    manual surgical instrument - Product Code HNN
  • Reason
    Product sterility may be compromised due to incomplete package seal.
  • Action
    On 12/26/2006 BD Medical, Ophthalmic Systems mailed a recall notification letter to US Distributors and US OEM''s. Customers are instructed to return any affected products to BD for a replacement. On 1/10/07, the firm expanded the recall to additional lots. Those lots are noted with an asterisk.

Device

Device Recall BD Beaver
  • Model / Serial
    Lot Numbers: 6158640, 6215941, 6258011
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide, including USA, Asia, Australia, Canada, Mexico, Taiwan, Singapore, Korea, and Japan.
  • Product Description
    BD Beaver¿ Mini-Blade, Blade Mini Orthopedic 1.31 in, Catalog Number: 376100
  • Manufacturer
    Becton Dickinson and Company

Manufacturer

Becton Dickinson and Company
  • Manufacturer Address
    Becton Dickinson and Company, 411 Waverley Oaks Rd Ste 2229, Waltham MA 02452-8448
  • Source
    USFDA