Events

Recall of Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

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
    72362
  • Event Risk Class
    Class 2
  • Event Number
    Z-0194-2016
  • Event Initiated Date
    2015-10-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140768
  • 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, for peritoneal dialysis, disposable - Product Code KDJ
  • Reason
    Leakage from the inlet port of the 15l cycler drainage bags.
  • Action
    Baxter sent an Urgent Product Recall letter dated October 8, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The recalling firm will ask customers to locate and separate all affected products, contact the recalling firm to arrange for a return, and complete the customer reply form. Further questions, please call (800) 422-9837.

Device

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
  • Model / Serial
    H15C11095
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution and Internationally to Canada.
  • Product Description
    Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path
  • 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