Events

Recall of Transfer Set

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

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
    76394
  • Event Risk Class
    Class 2
  • Event Number
    Z-2246-2017
  • Event Initiated Date
    2014-04-28
  • Event Date Posted
    2017-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-07-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153044
  • 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
    Connection issues between the pd transfer set catheter connector and an adapter may lead to leaks and contamination of the fluid pathway which may result in peritonitis.
  • Action
    On April 28, 2014, firm sent an Urgent Product Recall to US customers via USPS 1st class mail. Baxter requested customers to locate and remove all affected product from their facility, and contact Baxter Healthcare Center for Service to arrange for return and credit. 100%, all non-respondents would be contacted by phone. All affected product would be destroyed. For general questions regarding this communication , contact The Center for One Baxter at 1-800-422-9837 , Monday through Friday, between the hours of 8:00AM and 5:00 PM Central Time.

Device

Transfer Set
  • Model / Serial
    Product Code 5C4483; Lot# H12030047
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution and Internationally to Canada and Malaysia
  • Product Description
    Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. 1 Unit. Sterile. Baxter Healthcare Corporation, Deerfield, IL 60015 USA
  • Manufacturer
    Baxter Healthcare Corporation

Manufacturer

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