BEUDAMED
    FDA Enforcement Class II Terminated

    BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.

    Recall: Z-2673-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2673-2014
    Event ID
    69047
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 1, 2014
    Initiation Date
    July 22, 2014
    Classification Date
    September 22, 2014
    Termination Date
    April 21, 2015
    Address
    1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.

    Reason

    BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).

    Code Info

    REF #306553 Lot numbers 3024261 - exp 12-2015 3046276 - exp 01-2016 4128353 - exp 04-2017

    Distribution

    Nationwide Distribution.

    Quantity

    3,088,320 units