BEUDAMED
    FDA Recall Terminated

    ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT

    Recall: Z-0132-2016 · Initiated May 21, 2015

    Recall

    Recall Number
    Z-0132-2016
    Event Number
    71260
    Firm
    Baxter Healthcare Corp
    FEI Number
    1417572
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 21, 2015
    Posted
    October 16, 2015
    Terminated
    May 10, 2017
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT

    Reason

    Potential for a leak at the tubing to luer bond.

    Action

    Baxter sent their consignees a recall letter dated 05/21/2015 with the following instructions: Actions to betaken if product was purchased directly from Baxter : 1. 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 and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number(s) and quantity of product to be returned ready when calling. 3. Complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to [email protected] . Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 4. If you distribute this product to other facilities or departm ents within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, distributor/reseller, or Original Equipment Manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers. Action to be taken if product was purchased from a distributor: 1. 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 and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00pm central time, Monday through Friday. 3. Pl ease note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to the

    Distribution

    Domestic Only

    Quantity

    23,600