Events

Recall of Device Recall Baxter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxter Corporation Englewood.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70128
  • Event Risk Class
    Class 2
  • Event Number
    Z-1227-2015
  • Event Initiated Date
    2014-12-29
  • Event Date Posted
    2015-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132282
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Dispenser, liquid medication - Product Code KYX
  • 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 fca@baxter.com. 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.

Device

Device Recall Baxter
  • Model / Serial
    All DiscPac products are affected within expiry up to October 2017
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product 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.
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • Manufacturer Address
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA