Events

Recall of Device Recall Extraneal & Dineal PD Solution w/Automated PD Set w/Cassette

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

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
    62528
  • Event Risk Class
    Class 2
  • Event Number
    Z-2132-2012
  • Event Initiated Date
    2012-07-06
  • Event Date Posted
    2012-08-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110855
  • 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
    Baxter discovered that a baxter technical service representative was providing incorrect instructions for inspection of solution bags for a blocked frangible prior to connection to the automated pd set with cassette.
  • Action
    Baxter Healthcare Corp. sent "Important Product Information" letters dated July 6, 2012 to the affected home patients and their clinicians, via first class mail on the same date. The letter identified the product, problem and actions to be taken. The customers were instructed to refer to the Extraneal and/or Dineal package insert, Directions For Use - Preparation for Administration and the HomeChoice APD Systems At-Home Guide for proper procedures to connect to a solution line. Customers are instructed to retain a copy of the letter. The customers were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Global Technical Services, Renal Technical Support at 1-800-553-6898, option 1, 24 hours a day. For questions regarding this recall call 1-800-422-9837.

Device

Device Recall Extraneal & Dineal PD Solution w/Automated PD Set w/Cassette
  • Model / Serial
    all lots and serial numbers
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution includingArizona, California, Ohio, Pennsylvania and Virginia.
  • Product Description
    Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system is a personal cycler automated peritoneal dialysis system for pediatric and adult renal patients with fill volumes ranging from 60 mL to 3000 mL. || DIANEAL Low Calcium peritoneal dialysis solutions are indicated for use in chronic renal failure patients being maintained on peritoneal dialysis. - and- The Personal Cycler Peritoneal Dialysis System [cycler and ancillary sets] is used for automatic control of dialysate solution exchanges in treatment of renal failure patients undergoing peritoneal dialysis. The Personal Cycler System automatically cycles a prescribed volume of dialysis solution into and out of the peritoneal cavity during the dialysis treatment.
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 S Waukegan Rd, Waukegan IL 60085-6730
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA