BEUDAMED
    FDA Enforcement Class II 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 · Reported June 22, 2016

    Enforcement

    Recall Number
    Z-1989-2016
    Event ID
    74045
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Excelsior Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 22, 2016
    Initiation Date
    April 28, 2016
    Classification Date
    June 14, 2016
    Termination Date
    August 8, 2017
    Address
    1933 Heck Ave, Neptune, NJ, 07753-4428, United States

    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.

    Code Info

    Product Code, Lot number, Expiration date. 513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017

    Distribution

    US Nationwide distribution.

    Quantity

    184,500