BEUDAMED
    FDA Recall Terminated

    Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

    Recall: Z-0731-2016 · Initiated December 21, 2015

    Recall

    Recall Number
    Z-0731-2016
    Event Number
    72946
    Firm
    Baxter Corporation Englewood
    FEI Number
    1419106
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 21, 2015
    Posted
    January 30, 2016
    Terminated
    August 18, 2016
    Address
    9540 Maroon Cir, Unit 400, Englewood, CO, 80112-5731

    Description

    Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)

    Reason

    All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product.

    Action

    An Urgent Product Recall notification was sent to consignees via USPS, first class mail on 12/21/15. Baxter Healthcare has asked customers to do the following: l. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return, credit and alternative products. 3. Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. 4. Communicate the contents of the letter to your staff if affected products are distributed to other facilities or departments. 5. Conduct a consumer-level recall for dealers, wholesalers, distributors, resellers, or Original Equipment Manufacturers that distributed affected product to other facilities.

    Distribution

    Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands.

    Quantity

    4,695