BEUDAMED
    FDA Recall Terminated

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    Recall: Z-1390-2008 · Initiated February 28, 2008

    Recall

    Recall Number
    Z-1390-2008
    Event Number
    46912
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    NZW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 28, 2008
    Posted
    April 4, 2008
    Terminated
    February 18, 2020
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    Reason

    Due to an increase of adverse events in Baxter single and multi-dose Heparin for injection products, which used the same active pharmaceutical ingredient (API) source as the HEP LOCK products

    Action

    A Press Release was issued on February 28, 2008. Recall notification letters , Urgent Product Recall, were sent on February 29, 2008, by overnight mail to customers/wholesalers/ distributors and dialysis center/renal home patients. Recall letters were also sent on March 7, 2008, to health care professionals

    Distribution

    Worldwide Distribution --Worldwide: USA including Puerto Rico, and countries of Germany, Guam, America Samoa, Marshal Islands, Northern Mariana Island/Virgin Islands, and Qatar . Accounts included wholesalers, pharmacies, hospitals, and clinic/renal home patients

    Quantity

    529,125 vials