Events

Recall of Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. || All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. || MAJOR PACK

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Windstone Medical, Inc..

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
    25830
  • Event Risk Class
    Class 2
  • Event Number
    Z-0753-03
  • Event Initiated Date
    2003-03-25
  • Event Date Posted
    2003-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-09-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26554
  • 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 and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel data.
  • Extra notes in the data
  • Reason
    Product has latex free symbol on package, yet contains latex components.
  • Action
    On 3/25/03 the firm contacted their customers by telephone. This was followed by a letter dated 3/25/03. Enclosed with the letter is a response form for the customer to fill out and return to the firm. Product is to be returned to the firm.

Device

Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and ...
  • Model / Serial
    Catalog number 002117-000 Lot numbers 000006595, 000006895
  • Product Classification
    Cardiovascular Devices
  • Distribution
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Product Description
    Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. || All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. || MAJOR PACK
  • Manufacturer
    Windstone Medical, Inc.

Manufacturer

Windstone Medical, Inc.
  • Manufacturer Address
    Windstone Medical, Inc., 1602 4th Ave North, Billings MT 59101
  • Source
    USFDA