FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(A
- Recall number
- Z-1277-2017
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Breast Pack, part number AMS3238(A Breast Pack, part number AMS4419(A Breast Pack, part number AMS4419(B Breast Pack, part number AMS5750 Breast Pack, part number AMS5750(A Breast Pack, part number AMS6120 Breast Pack, part number PSS1784(B Breast Pack, part number PSS2272(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
- 369 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 100106, 6/21/2019 100129, 9/30/2019 100132, 6/17/2019 100505, 10/6/2019 100805, 9/21/2019 85140, 7/28/2018 86315, 11/19/2018 87053, 9/12/2018 87623, 8/10/2019 87945, 10/29/2018 88185, 12/1/2018 88827, 10/10/2018 89726, 12/10/2018 94942, 1/10/2019 96754, 5/20/2019 97548, 5/19/2019 98079, 6/1/2019 98319, 6/24/2019 99056, 6/27/2019 99157, 6/15/2019 99711, 9/4/2019
- 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