BEUDAMED
    FDA Recall Terminated

    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

    Recall: Z-0143-2014 · Initiated September 10, 2013

    Recall

    Recall Number
    Z-0143-2014
    Event Number
    66249
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1417572
    Product Code
    OBK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 10, 2013
    Posted
    November 6, 2013
    Terminated
    June 5, 2015
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets.

    Reason

    The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events.

    Action

    Baxter sent an Urgent Product Recall notification dated September 16, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were advised to : 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use.The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and returning it to Baxter by either faxing it to 1-224-270-5457 or scanning and emailing it to [email protected]. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 1-888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling. Please have the product code and lot number(s) available. 4.If you are a dealer, wholesaler,or distributor/reseller that distributed any product to other facilities, please forward this communication. Baxter distributed this product to customers between June 19, 2013 and August 20, 2013. The Center for One Baxter is available at 1-800-422-9837, Monday through Friday during the hours of 8:00 am to 5:00 pm Central Time.

    Distribution

    Worldwide Distribution - USA (nationwide) and the country of Canada.

    Quantity

    628,992 units