BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2096-2015 · Initiated November 5, 2014

    Recall

    Recall Number
    Z-2096-2015
    Event Number
    69762
    Firm
    Custom Healthcare Systems, Inc.
    FEI Number
    1121091
    Product Code
    GCB
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    November 5, 2014
    Posted
    July 17, 2015
    Terminated
    January 12, 2016
    Address
    4205 Eubank Rd, Richmond, VA, 23231-4328

    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.

    Action

    Custom Healthcare System sent an Urgent Product Recall letter dated November 5, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. PLEASE CHECK YOUR INVENTORY AND QUARANTINE ANY AFFECTED PRODUCT MATCHING THE DESCRIPTIONS ABOVE. Call 804 (421-5959) with regards to returning the affected products. Return Authorizations will be issued and product pickup and return will be scheduled.

    Distribution

    US Distribution to CT.

    Quantity

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