Events

Recall of Hand Tray

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
    71968
  • Event Risk Class
    Class 2
  • Event Number
    Z-0205-2017
  • Event Initiated Date
    2015-04-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149768
  • 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, part # 13140, of the custom ams kit were recalled because gloves may contain splits or holes compromising sterility.
  • Action
    Aligned Medical Solutions (AMS) sent the Medtronic Urgent Medical Device for Devon Light Glove letter, dated April 23, 2015 to all affected consignees. Consignees were informed that the sterile kits assembled and distributed by AMS contain the recalled Devon COVER LIGHT HANDLE DISPOSABLE Glove (AMS part #13140 or Medtronic part # 571711) due to splits or holes. Consignees were advised to identify any remaining affected kits and follow the over-labeling instruction. At the time the kit is opened for use, any light gloves should be identified and disposed of pursuant to the medical waste policies in effect at your institution. AMS can provide replacement product if needed or you can contact your local Medtronic sales rep for sterile replacements as well. Due to the manufacturing process and finished sterilized packs in inventory, or at your facility, over labeling of inventory and/or future shipment affected by this recall will be labeled with a sticker attached to each pack. This sticker will read: RECALL NOTICE Medtronic announced the recall l of Devon Light Glove contained in this kit after it was sealed and sterilized. All other components in the kit are not affected by this recall. 1. At the time the kit is opened for use any Light Glove manufactured by Medtronic should be identified and set aside 2. The recalled light glove should be rendered unusable to protect against inadvertent use and disposed of pursuant to the medical waste policies in effect at your institution. Consignees should complete the attached Reply Form and fax to AMS at 406-256-9875. For any questions about this recall, please call 321-527-7714. For questions regarding this recall call 404-259-6387.

Device

Hand Tray
  • Model / Serial
    Lot numbers/Expiration dates:  62742 2/28/2014 65112 3/23/2014 65816 4/24/2014 56706 5/15/2014 66648 7/21/2014 66649 7/21/2014 66165 7/25/2014 57524 9/1/2014 57338 9/20/2014 57977 9/22/2014 56883 9/24/2014 57057 9/24/2014 57523 9/25/2014 58348 1/3/2015 58349 1/4/2015 59680 1/17/2015 60694 1/24/2015 59678 1/25/2015 59679 1/26/2015 59221 1/28/2015 60104 1/29/2015 61738 4/24/2015 61740 6/11/2015 64688 6/19/2015 63590 6/22/2015 63772 6/22/2015 64002 6/22/2015 61739 6/27/2015 63257 6/28/2015 67941 2/11/2016 69813 3/23/2016 69812 3/26/2016 70306 3/30/2016 70581 3/30/2016 68432 6/1/2016 68433 6/9/2016 68006 6/12/2016 68578 6/13/2016 68008 6/30/2016 68894 6/30/2016 75064 7/30/2016 75200 7/30/2016 75500 7/30/2016 75803 7/30/2016 71902 9/10/2016 70989 9/21/2016 72308 9/24/2016 72754 9/24/2016 71238 9/25/2016 74820 11/9/2016 73337 11/15/2016 73397 11/15/2016 74294 11/24/2016 72983 11/25/2016 73566 11/28/2016 78172 4/16/2017 78171 4/19/2017 77607 4/23/2017 76467 4/24/2017 77068 4/24/2017 78380 4/24/2017 80630 4/24/2017 79474 4/25/2017
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
  • Product Description
    Hand Tray PSS2365(A, PSS2365(B, PSS2365(C, PSS2365(D || PSS2365(E, || convenience custom kits used for general surgery in hospital operating room
  • 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