FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
- Recall number
- Z-1261-2017
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Arthroscopy Pack, part number AMS2938 Arthroscopy Pack, part number AMS3639 Arthroscopy Pack, part number AMS4765 Arthroscopy Pack, part number PSS1799 Arthroscopy Pack, part number PSS1845(A
- Status
- Terminated
- Initiated
- 2017-01-11
- Posted
- 2017-02-28
- Terminated
- 2017-05-03
- Reason
- The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
- Root cause
- Nonconforming Material/Component
- Action
- AMS notified their consignees by Email, Fax, and Phone on 11/11/2017. AMS sent the notification letter, dated January 11, 2017, and provided yellow stickers "Recall Notice" to customers. They are advised to over-label the affected AMS kits at their facilities. Customers were instructed to place sticker in such a way that it would be immediately noticed but should not cover up or conceal any pertinent information such as Pack Number, Pack Name, Lot Number or Expiration Date on a kit. Customers with questions can call Vicki Davis at 321-527-7714 or send email to vdavis@alignedmedicalsolutions.com.
- Quantity
- 1,081 kits
- Distribution
- Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
- Lot, serial or model codes
- Lot Numbers and Expiration Dates 83622, 5/19/2018 84374, 5/24/2018 84729, 5/17/2017 84897, 5/26/2018 84946, 6/24/2017 85171, 6/9/2018 85363, 7/20/2017 85548, 7/15/2018 85696, 8/22/2018 85698, 7/21/2017 86510, 9/29/2018 86687, 9/5/2018 86889, 7/11/2017 86909, 9/12/2018 87156, 8/1/2018 87157, 9/5/2018 87159, 10/23/2017 87289, 10/17/2017 87978, 10/31/2017 88401, 10/7/2017 88549, 10/28/2017 88656, 12/7/2017 89219, 12/22/2017 89904, 1/23/2017 94742, 12/29/2017 95143, 12/4/2017 95284, 2/2/2018 95315, 2/20/2018 95840, 2/13/2018 96006, 1/7/2018 96469, 2/27/2018 96631, 1/8/2018 96821, 3/25/2018 96931, 2/1/2018 97751, 3/2/2018 98923, 3/20/2018 98971, 9/19/2018
- 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
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