Events

Recall of Device Recall Baxter Interlink System, YType Solution Set, 78 (2.0m), 2 Injection Sites, Male Luer Lock Adapter

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

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
    72787
  • Event Risk Class
    Class 2
  • Event Number
    Z-0606-2016
  • Event Initiated Date
    2015-11-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142211
  • 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
    Set, administration, intravascular - Product Code FPA
  • Reason
    Potential for dark loose particulate matter (400 microns or smaller) on the spike of the spike adapter or solution set.
  • Action
    Baxter sent an Urgent Product Recall letter by letter on 11/30/2015 to affected customers. The recall was extended to the consumer/user level. The letter instructed customers to locate and remove all affected product, contact Baxter Healthcare Center for Service to arrange for return of affected products and credit and complete the enclosed Baxter Customer Reply Form and return it to Baxter by either fax or scanned email.

Device

Device Recall Baxter Interlink System, YType Solution Set, 78 (2.0m), 2 Injection Sites, Male Lu...
  • Model / Serial
    Lot Numbers: GR324012, GR325322, GR326769, and GF328518
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution and the country of Canada
  • Product Description
    Baxter INTERLINK System, Y-Type Solution Set, 78 (2.0 m), 2 Injection Sites, Male Luer Lock Adapter, 1C8581 s, || Product Usage: || C8581: For the administration of fluids from a container into the patients vascular system through a vascular access device. || .
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA