Events

Recall of Basic 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
    71968
  • Event Risk Class
    Class 2
  • Event Number
    Z-0147-2017
  • 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=149615
  • 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

Basic Pack
  • Model / Serial
    Lot Numbers/Expiration Dates:  56104 4/5/2015 56836 6/19/2016 57228 5/22/2016 57473 6/26/2016 58063 8/6/2016 58068 7/11/2016 58357 7/31/2016 58588 4/10/2015 59298 3/11/2015 59847 9/13/2015 60274 11/4/2015 60353 7/18/2015 60354 7/22/2015 60649 10/28/2015 60797 11/5/2015 61071 10/3/2015 61873 11/28/2015 62203 11/7/2015 62456 11/28/2015 62945 11/2/2015 63065 9/3/2015 63204 11/11/2015 63665 1/29/2016 64166 1/6/2016 64470 1/13/2016 64559 1/29/2016 64750 1/18/2016 64819 10/11/2015 64976 1/14/2016 65020 6/27/2017 65048 11/1/2015 65116 1/17/2016 65411 11/1/2015 65442 11/15/2015 65737 2/15/2016 65804 2/25/2015 65879 12/22/2015 66321 11/12/2015 66395 6/27/2015 66696 11/4/2015 67207 11/16/2015 67521 8/21/2015 67551 7/23/2016 67694 5/2/2015 67700 7/26/2016 67701 7/4/2016 67810 8/10/2016 67966 7/15/2016 68145 8/28/2016 68387 7/6/2016 68410 9/21/2016 68413 9/25/2015 68710 9/13/2016 68711 9/22/2016 68721 9/18/2016 68822 9/5/2016 68857 2/21/2015 69056 11/26/2017 69067 9/20/2016 69191 9/16/2016 69343 9/5/2016 69344 9/11/2016 69345 9/14/2016 69549 9/20/2016 69646 12/24/2016 69893 3/29/2017 70157 9/12/2016 70176 12/12/2015 70966 7/11/2016 70970 10/10/2016 71156 12/27/2016 71450 2/13/2015 71634 1/5/2017 71634 1/5/2017 71788 10/20/2016 71945 1/3/2017 71955 2/7/2015 71987 1/21/2017 72112 3/24/2017 72306 1/7/2017 72490 3/21/2017 72616 3/23/2017 72640 3/12/2017 72978 3/1/2017 72978 3/1/2017 73191 8/21/2016 73203 3/8/2017 73204 4/20/2017 73428 4/4/2017 73645 1/22/2017 73646 4/5/2017 73826 7/27/2017 73933 4/13/2017 73933 4/13/2017 73934 5/3/2017 74061 1/16/2017 74442 4/20/2017 74460 5/9/2017 75094 5/4/2017 75255 6/21/2017 75455 6/25/2016 75646 7/16/2017 75745 6/27/2016 75830 7/9/2017 75902 7/11/2017 76026 7/2/2017 76034 7/23/2017 76083 4/23/2017 76141 7/9/2017 76142 4/23/2017 76152 7/30/2016 76161 8/30/2017 76236 7/15/2016 76662 10/25/2017 76680 8/29/2017 76917 8/5/2017 76948 8/30/2017 77315 10/1/2017 77434 8/14/2017 77518 9/27/2017 77771 10/9/2017 77845 8/23/2017 78027 9/2/2017 78325 8/26/2017 78337 11/9/2017 78641 9/2/2017 78743 9/19/2017 78879 11/2/2017 78980 1/6/2018 79248 9/10/2017 79315 1/17/2018 79497 1/2/2018 79657 2/2/2018 80442 2/26/2018 80608 1/19/2018 80916 1/9/2018
  • 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
    Basic Pack, Kit part numbers AMS1388(A, AMS1520, AMS1868, AMS1868(A, AMS1868(B, AMS2608, AMS2608(A, AMS2728, AMS2728(A, AMS2758, AMS2758(A, AMS2972, AMS4264, AMS4309, PSS1833, and PSS1848(A. || 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