BEUDAMED
    FDA Recall Terminated

    Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432

    Recall: Z-1173-2009 · Initiated February 6, 2009

    Recall

    Recall Number
    Z-1173-2009
    Event Number
    51292
    Firm
    Medtronic Inc
    FEI Number
    3001504994
    Product Code
    LDF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 6, 2009
    Posted
    April 14, 2009
    Terminated
    May 7, 2011
    Address
    710 Medtronic Pkwy, Minneapolis, MN, 55432-5603

    Description

    Medtronic STREAMLINE Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, Medtronic, INC., Minneapolis, MN 55432

    Reason

    Medtronic is recalling one lot of STREAMLINE Bipolar Myocardial Temporary Pacing Leads, Model 6495, Lot JGD880205F. This lot of product contains incorrect inner pouch labeling, instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have b

    Action

    Consignees were sent on 2/6/09 a Medtronic " Urgent Medical Device Recall Notice" dated February 6, 2009. The letter was sent to Risk Mangers. The letter described the product, problem, and requested the removal and quarantine of the affected, unused product. They asked consignees to sign and return the attached recall certificate regarding the status of affected product remaining at their facility. Their Medtronic Sales Representative will contact them to arrange the return of any affected inventory or customers may follow the instructions provided on the attached certificate.

    Distribution

    Nationwide Distribution -- including states of AK, AZ, CA, CO, CT, ID, IL, IN, KS, MI, MS, NE, NV, NH, NM, NY, NC, OH, OR, PA, TN, TX, VA, WA, and WI.

    Quantity

    612