BEUDAMED
    FDA Recall Terminated

    BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452

    Recall: Z-0453-2008 · Initiated November 20, 2007

    Recall

    Recall Number
    Z-0453-2008
    Event Number
    45887
    Firm
    Becton Dickinson and Company
    FEI Number
    1211998
    Product Code
    HNM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 20, 2007
    Posted
    December 11, 2007
    Terminated
    February 29, 2012
    Address
    411 Waverley Oaks Rd, Ste 2229, Waltham, MA, 02452-8448

    Description

    BD Visitec Nucleus Hydrodissector, .40 x 22 mm, (27Gx 7/8 in) , Sterile, Catalog #/REF #: 585155, Becton, Dickinson and Company, Waltham, MA 02452

    Reason

    No Fluid Flow or Restricted Fluid Flow: Nucleus Hydrodissector(s) were found to have reduced or no fluid flow.

    Action

    The recalling firm notified consignees of the recall through a Voluntary Medical Device Recall letter and phone call on 11/20/2007. Instructions for product return were provided and a telephone number for questions was given (Customer Service 1-866-906-8080 Option 2)

    Distribution

    Nationwide-USA including the states of CA, CO, CT, FL, GA, HI, IL, IN, KS, LA, MA, MD, MO, NC, NJ, NY, OH, PA, SC, TN, VA, and WA

    Quantity

    40,450