BEUDAMED
    FDA Recall Terminated

    ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.

    Recall: Z-1437-2012 · Initiated March 30, 2012

    Recall

    Recall Number
    Z-1437-2012
    Event Number
    61622
    Firm
    Teva Pharmaceuticals USA, Inc.
    FEI Number
    2517175
    Product Code
    KDL
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    March 30, 2012
    Posted
    April 18, 2012
    Terminated
    October 25, 2012
    Address
    650 Cathill Rd, Sellersville, PA, 18960-1512

    Description

    ViaSpan Cold Storage Solution 1000mL Bag distributed under the Barr/Duramed Pharmaceuticals label (10 x 1000mL bags). Disposable kidney perfusion set.

    Reason

    Lack of assurance of sterility

    Action

    Teva Pharmaceuticals USA sent an "URGENT MEDICAL DEVICE RECALL-RETAIL LEVEL" letter dated March 30, 2012. The letter identifies the problem, product, and actions to be taken by the customers. The letter instructs customers to check their inventory and to discontinue distribution of the affected product. A Stock Response Form was enclosed for customers to complete and return via fax to 817-868-5362. Contact Teva Customer Services at 800-545-8800 for questions regarding this notice.

    Distribution

    Nationwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CT, DE, FL, GA, IA, IL, KS, KY, LA, MA, MD, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV and Washington, D.C.

    Quantity

    4,070