BEUDAMED
    FDA Enforcement Class II Terminated

    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

    Recall: Z-2096-2015 · Reported July 29, 2015

    Enforcement

    Recall Number
    Z-2096-2015
    Event ID
    69762
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Custom Healthcare Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 29, 2015
    Initiation Date
    November 5, 2014
    Classification Date
    July 17, 2015
    Termination Date
    January 12, 2016
    Address
    4205 Eubank Rd, N/A, Richmond, VA, 23231-4328, United States

    Description

    Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.

    Reason

    An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD.

    Code Info

    Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15

    Distribution

    US Distribution to CT.

    Quantity

    3 Cs-Lot#92414 , 25 Cs-Lot#100214, 24 Cs-Lot#100914