FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
- Recall number
- Z-0231-2017
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Major General Pack, Kit number 002645-11 and 002645-12 convenience custom kits used for general surgery in hospital operating room
- Status
- Terminated
- Initiated
- 2015-04-22
- Posted
- not on file
- Terminated
- 2016-10-25
- 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.
- Root cause
- Unknown/Undetermined by firm
- 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.
- Quantity
- 852 kits
- Distribution
- Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.
- Lot, serial or model codes
- Lot Numbers Expiration Dates 58579 8/20/2013 62097 12/4/2013 61593 12/15/2013 59838 12/30/2013 64762 12/31/2013 60645 1/13/2014 59179 1/14/2014 67196 1/31/2014 65990 2/28/2014 63190 9/15/2014 62540 9/20/2014 67875 9/28/2014 65484 9/30/2014 69395 5/2/2016 56674 5/29/2016 71054 6/3/2016 57460 6/14/2016 68944 6/20/2016 70475 8/10/2016
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSY
- Firm FEI
- 1000125955
- Firm city
- Billings
- Firm state
- MT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28