Windstone Medical Packaging, Inc.: Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A convenience custom kits used for general surgery in hospital operating room

Recall number

Z-0211-2017

Recalling firm

Windstone Medical Packaging, Inc.

Product

Knee Arthroscopy Pack AMS2610, AMS2610(A, AMS3236, PSS2188(A, and PSS2208(A 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

not on file

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:  63879 1/23/2014 58286 3/18/2014 58810 6/21/2014 62512 10/18/2014 63024 12/13/2014 65774 2/25/2015 68072 4/17/2015 68548 4/25/2015 70982 11/26/2015 73402 3/14/2016 74837 3/22/2016 75198 4/20/2016 67703 7/1/2016 78551 7/30/2016 78600 7/30/2016 68823 9/11/2016 68713 9/20/2016 71080 12/26/2016 72020 1/10/2017 73647 1/28/2017 73205 3/9/2017 73034 3/23/2017 77621 7/21/2017 79992 8/1/2017 77815 8/11/2017 80859 8/31/2017 77783 10/10/2017 75744 10/21/2017 79326 1/13/2018

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

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

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