BEUDAMED
    FDA Recall Terminated

    Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.

    Recall: Z-1989-2016 · Initiated April 28, 2016

    Recall

    Recall Number
    Z-1989-2016
    Event Number
    74045
    Firm
    Excelsior Medical Corp
    FEI Number
    1000122362
    Product Code
    NZW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 28, 2016
    Posted
    June 14, 2016
    Terminated
    August 8, 2017
    Address
    1933 Heck Ave, Neptune, NJ, 07753-4428

    Description

    Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.

    Reason

    Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.

    Action

    Excelsior Medical Inc. sent a recall letter on 4/29/2016 via certified mail. Customers are instructed to discontinue using the product subject to this recall. Customers are requested to complete the customer reply form and fax it (866) 807-3714, so arrangements can be made to return the product to Excelsior.

    Distribution

    US Nationwide distribution.

    Quantity

    184,500