BEUDAMED
    FDA Recall Terminated

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    Recall: Z-0194-2010 · Initiated September 29, 2009

    Recall

    Recall Number
    Z-0194-2010
    Event Number
    53471
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 29, 2009
    Posted
    November 13, 2009
    Terminated
    December 17, 2011
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.

    Reason

    Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.

    Action

    An Urgent Medical Device Recall Removal letter dated 09/29/2009 was sent to affected facilities and addressed to Risk Manager / Field Action Contact, beginning 09/29/2009. The letter explained the issue and identified product. Customers were asked to identify affected product within their inventory, segregate it and immediately return it to Boston Scientific. Customers will receive replacements for all recalled product that is returned. Customers were also to fax back to Boston Scientific the Reply Verification Tracking Form. Questions regarding this Recall Removal are directed to the local Sales Representative.

    Distribution

    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.

    Quantity

    9800 total (2373 US and 7427 OUS)