BEUDAMED
    FDA Recall Terminated

    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

    Recall: Z-1227-2015 · Initiated December 29, 2014

    Recall

    Recall Number
    Z-1227-2015
    Event Number
    70128
    Firm
    Baxter Corporation Englewood
    FEI Number
    1419106
    Product Code
    KYX
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    December 29, 2014
    Posted
    February 27, 2015
    Terminated
    August 8, 2016
    Address
    14445 Grasslands Dr, Englewood, CO, 80112-7062

    Description

    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

    Reason

    Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both single and case labels.

    Action

    Baxter sent an Safety Alert letter dated January 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1.Complete the enclosed 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 customer reply form promptly will prevent you from receiving repeat notices. 2. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. Action to be taken if you are an end-user and purchased product from a distributor or reseller: 1. Please forward a copy of this Safety Alert letter to other facilities or departments within your institutions to ensure that those locations are aware of this action. 2. Follow your supplier's reply process. Please do not return the customer reply form to Baxter. Action to be taken if you are a distributor: If you are a dealer, wholesaler, or distributor/reseller that distributed any product to other facilities, please notify your customers of this Safety Alert in accordance with your customary procedures. Further information and support For general questions regarding this communication, contact The Center for One Baxter at 800-422-9837, Monday through Friday, between the hours of 8:00 AM and 5:00 PM Central Time.

    Distribution

    Nationwide Distribution

    Quantity

    1,404,230