Events

Recall of Device Recall Baxter, MiniCap with PovidoneIodine solution

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
    68640
  • Event Risk Class
    Class 2
  • Event Number
    Z-1945-2014
  • Event Initiated Date
    2013-07-08
  • Event Date Posted
    2014-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128389
  • 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
    Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
  • Reason
    The white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil layer. the upper paper layer may serve as a protective barrier and help support overall packaging.
  • Action
    An Urgent Product Recall notification was mailed via U.S.P.S. first-class mail to facilities, (dialysis centers and distributors) on July 8, 2013 and mailed by first-class mail to home patients on July 11, 2013.

Device

Device Recall Baxter, MiniCap with PovidoneIodine solution
  • Model / Serial
    Lot Numbers: GD894535, GD894550
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in the states of AR, TN MO, KS, TX, MS, and AL.
  • Product Description
    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis.
  • 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