Events

Recall of Device Recall Open Procedure Pack

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Windstone Medical Packaging, 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
    76280
  • Event Risk Class
    Class 2
  • Event Number
    Z-1350-2017
  • Event Initiated Date
    2017-01-11
  • Event Date Posted
    2017-02-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152905
  • 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
    Light, surgical, ceiling mounted - Product Code FSY
  • Reason
    The medtronic cover light handle disposable gloves of the custom aligned medical solutions (ams) kits were recalled because gloves may contain splits or holes compromising sterility.
  • Action
    AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.

Device

Device Recall Open Procedure Pack
  • Model / Serial
    Lot number and expiration date  100206, 6/1/2018 100248, 7/9/2018 100438, 7/19/2018 100439, 8/29/2018 100853, 9/15/2018 86832, 10/10/2017 88268, 10/4/2017 89377 ,11/9/2017 89378, 12/9/2017 94967, 12/31/2017 95888, 1/5/2018 96199, 2/11/2018 97018, 1/9/2018 97019, 2/17/2018 97146, 4/28/2018 97301, 3/22/2018 97478, 6/13/2018 98189, 5/20/2018
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
  • Product Description
    Open Procedure Pack, part number AMS4596 || Open Procedure Pack, part number AMS4596(A || Open Procedure Pack, part number AMS4596(B
  • Manufacturer
    Windstone Medical Packaging, Inc.

Manufacturer

Windstone Medical Packaging, Inc.
  • Manufacturer Address
    Windstone Medical Packaging, Inc., 1602 4th Ave N, Billings MT 59101-1521
  • Manufacturer Parent Company (2017)
    Windstone Medical Packaging Inc.
  • Source
    USFDA