BEUDAMED
    FDA Recall Terminated

    Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR Excelsior Medical Neptune, NJ 07753 (800) 487-4276 Made in USA NDC 63807060055. Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal systems, in hemodialysis, and for peritoneal dialysis.

    Recall: Z-1707-2012 · Initiated May 7, 2012

    Recall

    Recall Number
    Z-1707-2012
    Event Number
    61823
    Firm
    Excelsior Medical Corp
    FEI Number
    1000122362
    Product Code
    NZW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 7, 2012
    Posted
    June 5, 2012
    Terminated
    September 12, 2013
    Address
    1933 Heck Ave, Neptune, NJ, 07753

    Description

    Heparin Lock Flush Solution 100 Unit/mL, USP 3 ml, 4 ml, 5mL, 6 ml fill in a 10 ml Flush Syringe ZR Excelsior Medical Neptune, NJ 07753 (800) 487-4276 Made in USA NDC 63807060055. Used to maintain patency of vascular access devices designed for intermittent infusion therapy. Export product for sale in Colombia are used for locking hemodialysis catheters, for heparinization of extracorporeal systems, in hemodialysis, and for peritoneal dialysis.

    Reason

    Some lots of Heparin Lock Flush, USP Syringes (3 mL fill in 10 ml syringe, 4 mL fill in 10 ml syringe, 5 mL fill in 10 ml and 6 ml in 10 ml syringe), failed Anti-Factor IIa assay for potency.

    Action

    Excelsior Medical sent an "URGENT MEDICAL DEVICE RECALL" letter dated May 4, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue using the affected product and to complete and return an attached Customer Reply Form via fax to (866) 807-3714. Contact Excelsior Medical Customer Service at (800) 487-4276 for questions regarding this recall. A second letter which included additional lots was sent out on 5/25/2012 with the date of 5/24/2012. A return response form was also included.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Brazil, Canada, and Colombia.

    Quantity

    34,230,500 units (596 lots)