Events

Recall of Device Recall MiniCap with ProvidoneIodine 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
    65254
  • Event Risk Class
    Class 2
  • Event Number
    Z-1565-2013
  • Event Initiated Date
    2013-05-21
  • Event Date Posted
    2013-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118383
  • 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
    Leaking pouches.
  • Action
    The firm, Baxter Healthcare Corporation sent an "URGENT PRODUCT RECALL" letter dated May 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. For general questions regarding this communication, contact The Center for One Baxter at 1-800-422-9837.

Device

Device Recall MiniCap with ProvidoneIodine solution
  • Model / Serial
    Lot Number GD893891
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Baxter, MiniCap with Povidone-Iodine solution, 5C4466P, Baxter Healthcare Corporation. For dialysis. || Intended to isolate the Easy-Lock connector of the solution transfer set.
  • 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