FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
- Recall number
- Z-1800-2017
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Vitrectomy Pack, part number AMS4952 Product packaged in a convenient manner for use in a general clinical procedure
- Status
- Terminated
- Initiated
- 2017-03-16
- Posted
- 2017-04-11
- Terminated
- 2017-06-06
- Reason
- AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- Root cause
- Nonconforming Material/Component
- Action
- AMS sent an Urgent Medical Device Recall letter dated March 16, 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 should check inventory and complete the Recall Reply Form. Fax the completed form to Aligned Medical Solutions at 407-804-8460 or email the completed form to vdavis@alignedmedicalsolutions.com. Customers can call Aligned Medical Solutions at 321-527-7714.
- Quantity
- 100 kits
- Distribution
- Nationwide Distribution including CA, CO, FL, GA, IA, KY, MA, MN, MO, ND, NJ, NV, OH, SD, TX, UT, WI, and WY.
- Lot, serial or model codes
- Lot numbers: 84384 85615 96957 99402
- 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