BEUDAMED
    FDA Recall Terminated

    Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA

    Recall: Z-0260-2008 · Initiated July 11, 2007

    Recall

    Recall Number
    Z-0260-2008
    Event Number
    38445
    Firm
    Boston Scientific Target
    FEI Number
    2939204
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    July 11, 2007
    Posted
    November 24, 2007
    Terminated
    December 5, 2007
    Address
    47900 Bayside Pkwy, Fremont, CA, 94538-6515

    Description

    Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters, Made in USA: 5905 Nathan Lane, Plymouth, MN 55442 USA

    Reason

    Mislabeling: Catheters were found to be mislabeled (100 cm labeled devices actually contains 90cm length catheter)

    Action

    Firm notified consignees by Urgent Medical Device Recall Letter dated 11 Jul 07 requesting return of product.

    Distribution

    Worldwide Distribution-USA, EU, Japan, South Korea, Mexico, Colombia, and Hungary.

    Quantity

    49 units