Events

Recall of Device Recall BD Beaver Slit Blade 3.0mm Straight

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bd Medical Systems.

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
    56170
  • Event Risk Class
    Class 2
  • Event Number
    Z-0822-2011
  • Event Initiated Date
    2010-06-24
  • Event Date Posted
    2010-12-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92832
  • 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
  • Reason
    Blades may contain defects at the blade tip or cutting edge.
  • Action
    BD Medical notified customers via letter dated 6/24/10 to discontinue use of product and remove from inventory. Customers were instructed to complete the customer response form and fax to BD Medical. BD Medical was to contact customers upon receipt of the customer response form to arrange for replacement. Unused product was to be returned to: BD Medical Ophthalmic Systems Attn: WT-12582 411 Waverly Oaks Road Building 2, Suite 229 Watham, Massachusetts 02452-8402 For questions regarding this recall call 1-781-906-7952.

Device

Device Recall BD Beaver Slit Blade 3.0mm Straight
  • Model / Serial
    Lot #9138996 Exp: 2014-05
  • Distribution
    Nationwide Distribution
  • Product Description
    BD Beaver Slit Blade 3.0mm Straight || Part Number: 375521 || The BD Beaver Slit Blade is used to perform the main incision through which instruments are inserted during cataract surgery.
  • Manufacturer
    Bd Medical Systems

Manufacturer

Bd Medical Systems
  • Manufacturer Address
    Bd Medical Systems, 411 Waverley Oaks Rd, Waltham MA 02452-8405
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA