FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Set Up Pack, part number PSS3574(A
- Recall number
- Z-1366-2017
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Set Up Pack, part number PSS3574(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
- 820 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 number and expiration date 100490, 8/7/2019 84969, 5/27/2018 85341, 6/15/2018 85566, 6/8/2018 86926, 8/2/2018 86927, 7/16/2018 87263, 10/10/2018 89647, 11/23/2018 89913, 10/2/2018 94889, 11/28/2018 95156, 11/14/2018 95674, 12/27/2018 96088, 1/25/2019 96849, 3/7/2019 96990, 5/7/2019 97637, 5/27/2019 98073, 5/23/2019 98373, 5/30/2019 99444, 6/24/2019
- 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