Events

Recall of CLOWARD 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-0758-03
  • 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=26563
  • 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
  • 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

CLOWARD PACK
  • Model / Serial
    Catalog number CPA-2374 Lot numbers 007253692, 000000329, 000000644, 000001197, 000001988, 000002422, 000002854, 000003293, 000003400, 000004000, 000004498, 000004845, 000005665, 000005763, 000005783, 000006309, 000006530, 000006766
  • Distribution
    The firm distributed to 13 hospitals and medical facilities located in CO, IN, MI, MN, MT, UT, and WA.
  • Product Description
    CLOWARD PACK
  • Manufacturer
    Windstone Medical, Inc.

Manufacturer

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