Events

Recall of Device Recall APD Set with Cassette 3Prong Peritoneal Dialysis 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
    75998
  • Event Risk Class
    Class 2
  • Event Number
    Z-1056-2017
  • Event Initiated Date
    2016-12-16
  • Event Date Posted
    2017-01-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151903
  • 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
    System, peritoneal, automatic delivery - Product Code FKX
  • Reason
    Customer complaints received for the presence of leaks.
  • Action
    An Urgent Product Recall communication will be sent to affected customers via U.S.P.S., first class mail.

Device

Device Recall APD Set with Cassette 3Prong Peritoneal Dialysis Set
  • Model / Serial
    H16F16088
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US only
  • Product Description
    APD Set with Cassette 3-Prong Peritoneal Dialysis Set || Indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD systems in clinical and home use settings.
  • 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