FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
- Recall number
- Z-1330-2017
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Laparoscopic Pack, part number AMS2499 Laparoscopic Pack, part number AMS2499(A Laparoscopic Pack, part number AMS2499(B
- 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
- 1056 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 84903, 7/25/2018 85836, 8/22/2018 86720, 9/30/2018 86873, 8/16/2018 87104, 8/30/2018 88049, 10/29/2018 88170, 10/5/2018 88378, 11/15/2018 88379, 12/2/2018 89576, 11/15/2018 89577, 12/2/2018 89721, 12/17/2018 94931, 1/29/2019 94932, 1/5/2019 95274, 1/27/2019 95596, 1/13/2019 95983, 6/10/2019 96593, 5/1/2019 97448, 5/28/2019 97653, 6/17/2019 97654, 6/24/2019 97655, 6/21/2019
- 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