Events

Recall of Custom 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-0165-2017
  • 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=149660
  • 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

Custom Pack
  • Model / Serial
    Lot Numbers/ Expiration Dates:  60238 4/27/2014 63592 5/22/2014 61110 5/31/2014 64981 6/6/2014 64360 6/6/2014 63344 6/17/2014 62792 6/18/2014 63990 6/23/2014 61099 8/21/2014 59122 9/20/2014 65818 11/18/2014 72314 11/25/2014 57135 1/21/2015 65766 2/26/2015 73492 3/31/2015 59151 4/24/2015 57576 5/8/2015 70776 5/13/2015 58841 5/15/2015 57136 5/25/2015 59700 7/8/2015 60764 8/7/2015 61177 8/12/2015 61496 8/15/2015 59482 8/19/2015 60670 9/12/2015 60618 9/15/2015 60619 9/20/2015 61098 9/27/2015 65575 10/17/2015 65113 10/18/2015 60828 10/27/2015 62788 11/2/2015 61930 11/4/2015 61354 11/6/2015 66242 11/7/2015 65407 11/8/2015 62515 11/10/2015 65328 11/10/2015 65380 11/16/2015 62064 11/18/2015 61734 11/22/2015 63294 11/28/2015 63296 11/28/2015 63350 12/9/2015 63743 12/11/2015 62511 12/25/2015 63037 12/25/2015 63371 12/28/2015 63295 12/28/2015 64672 1/13/2016 63423 1/16/2016 63746 1/22/2016 63751 1/23/2016 61978 1/28/2016 75438 5/18/2016 57063 5/22/2016 71254 5/26/2016 56759 5/31/2016 57500 6/20/2016 75530 6/25/2016 56878 7/5/2016 67109 7/5/2016 68691 7/7/2016 66642 7/11/2016 57583 7/12/2016 67283 7/19/2016 57518 7/21/2016 67771 7/29/2016 68690 7/30/2016 58316 8/13/2016 58533 8/16/2016 58916 8/23/2016 58970 8/23/2016 68245 9/3/2016 69838 9/15/2016 69469 9/20/2016 66608 9/21/2016 70428 9/29/2016 70203 10/21/2016 69728 11/2/2016 68983 11/16/2016 70998 12/17/2016 71524 12/17/2016 72094 12/18/2016 72507 1/10/2017 72343 1/15/2017 70557 1/17/2017 72354 1/20/2017 72864 1/21/2017 73491 1/22/2017 73575 1/27/2017 72972 3/5/2017 73284 3/7/2017 72863 3/15/2017 73094 3/24/2017 72768 3/29/2017 73764 4/18/2017 74120 4/19/2017 73432 5/21/2017 74424 5/22/2017 74838 5/23/2017 76477 7/20/2017 75810 7/22/2017 75363 7/23/2017 74113 7/27/2017 75811 7/28/2017 75818 7/29/2017 78094 8/29/2017 77196 8/30/2017 77752 9/2/2017 78208 9/15/2017 77605 9/19/2017 76282 9/30/2017 77372 10/8/2017 76910 10/24/2017 78629 11/3/2017 78209 11/3/2017 78766 11/9/2017 79083 11/24/2017 78611 1/4/2018 78612 1/9/2018 78115 1/11/2018 79596 1/24/2018 79230 2/1/2018 79229 2/19/2018 79812 2/28/2018
  • 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
    Custom Pack, Kit numbers PSS1300, PSS1471(A, PSS1771, PSS2135(A, PSS2135(B, PSS2207, PSS2412(B, PSS2798, PSS2798(A, PSS2798(B, PSS3054, PSS3463, TVS4011NI(J, TVS4028(A, and TVS4070. || 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