Events

Recall of Device Recall Baxter SelfRighting Luer Lock Tip Cap

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
    69934
  • Event Risk Class
    Class 2
  • Event Number
    Z-0871-2015
  • Event Initiated Date
    2014-12-04
  • Event Date Posted
    2014-12-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131999
  • 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
    Baxter corporation initiated a recall of two lots of self-righting luer lock tip caps because they were distributed prior to closure of the validation.
  • Action
    Baxter sent an Urgent Product Recall letter via USPS to all affected customers dated December 8, 2014.The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to locate and remove all affected product from their facility, and to contact Baxter Healthcare to arrange for return and credit.Returned products will be destroyed./discarded. If you have questions regarding the content of the communication, please call The Center for One Baxter at (1-800) 422-9837, between the hours of 8:00am and 5:00pm Central time.

Device

Device Recall Baxter SelfRighting Luer Lock Tip Cap
  • Model / Serial
    Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.
  • Product Description
    Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile
  • 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