Events

Recall of Device Recall BD Visitec High Viscosity Injector 4mm Hammer

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
    57472
  • Event Risk Class
    Class 2
  • Event Number
    Z-2161-2011
  • Event Initiated Date
    2010-12-17
  • Event Date Posted
    2011-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96306
  • 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
    Cannula, ophthalmic - Product Code HMX
  • Reason
    Restricted or no fluid flow for visitec high viscosity injector.
  • Action
    Beaver Visitec (BVI) notified customers via telephone and by sending an Urgent Recall Customer Notification letter dated December 7, 2010. The letter identified the product, the problem, and the action to be taken by the customer. , Customers were requested to return all unused product in their inventory for credit or refund and complete the attached Customer Response Form and return it by fax to 781-893-7957. Questions can be directed to Inside Sales Manager at 781-906-7952.

Device

Device Recall BD Visitec High Viscosity Injector 4mm Hammer
  • Model / Serial
    Lot #: 9314527, Exp Date: 2014-11; Lot #: 9347069, Exp Date: 2014-12; Lot #: 0019451, Exp Date: 2015-01; Lot #: 0048864, Exp Date: 2015-02; Lot #: 0111511, Exp. Date: 2015-04 Lot #: 0193966, Exp Date: 2015-01; Lot #: 0288626, Exp Date: 2015-01; Lot #: 0305287, Exp. Date: 2015-11
  • Product Classification
    Ophthalmic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Israel, Jordan, Russia, Saudi Arabia, South Africa, Turkey, Iraq, Lebanon, Morocco, Tunisia, Syria, India, Argentina, Australia, Austria, New Zealand, China, UK, Germany, Russia, Belgium, Italy, France, Sweden, and Ireland.
  • Product Description
    BD Visitec || High Viscosity Injector 4mm [Hammer] .90 (20G) || Catalog Number: 585208 || High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and temporarily sutured into place.
  • 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