Events

Recall of Device Recall Baxter CAPD Solution Transfer Set for use with UVFlash

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
    30495
  • Event Risk Class
    Class 2
  • Event Number
    Z-0301-05
  • Event Initiated Date
    2004-11-05
  • Event Date Posted
    2004-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-05-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36005
  • 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
    Disconnection of the tubing at the clamp level of the uv flash transfer set.
  • Action
    Recall by letter dated 11/05/04. The customers were instructed to stop using this lot of product, return any stocks of the lot back to Baxter, and that replacement of the patient''s set be completed at the dialysis center.

Device

Device Recall Baxter CAPD Solution Transfer Set for use with UVFlash
  • Model / Serial
    Product code R5C4325, lot H03L12057, expiration date 12/31/08
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The entire lot was distributed overseas to Belgium, Sweden, Norway, the United Kingdom, Germany and France.
  • Product Description
    Baxter CAPD Solution Transfer Set for use with UV-Flash Germicidal Exchange Device, 1.2 m (48''); a sterile set consisting of a bag connector (spike connector), on-off clamp assembly, tubing and double sealing male Luer lock connector; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085; product code R5C4325
  • Manufacturer
    Baxter Healthcare Renal Div

Manufacturer

Baxter Healthcare Renal Div
  • Manufacturer Address
    Baxter Healthcare Renal Div, 1620 Waukegan Rd Bldg R, Mc Gaw Park IL 60085-6730
  • Source
    USFDA