BEUDAMED
    FDA Enforcement Class II Terminated

    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    Recall: Z-2295-2014 · Reported August 27, 2014

    Enforcement

    Recall Number
    Z-2295-2014
    Event ID
    68973
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ICU Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 27, 2014
    Initiation Date
    August 5, 2014
    Classification Date
    August 20, 2014
    Termination Date
    February 26, 2015
    Address
    951 Calle Amanecer, San Clemente, CA, 92673-6212, United States

    Description

    Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and other components. The affected lots are easily identifiable via the lot number printed on the pouch.

    Reason

    ICU Medical is recalling the BD PosiFlush Sterile Field Saline Flush Syringe because some unit packages may exhibit open seals which impacts package sterility and potentially product sterility.

    Code Info

    Lot No. 2705203

    Distribution

    Nationwide Distribution - USA including AL and MD.

    Quantity

    400 units