FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
- Recall number
- Z-1082-2024
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
- Status
- Open, Classified
- Initiated
- 2023-12-22
- Posted
- 2024-02-16
- Terminated
- not on file
- Reason
- Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Root cause
- Unknown/Undetermined by firm
- Action
- On January 22, 2024, Windstone Medical Packaging dba Aligned Medical Solutions (AMS) On December 22, 2023, Windstone Medical Packaging dba Aligned Medical Solutions (AMS) issued an "Urgent: Medical Device Recall notice via. E-Mail. AMS asked consignees to take the following actions: 1. Immediately check your inventory for the voluntary recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for all products affected by this recall. 3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity. 4. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5. Please complete the Recall Reply Form within 5 business days and return via email to vdavis@alignedmedicalsolutions.com even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement Nurse Assist product is needed.
- Quantity
- 475 kits
- Distribution
- US: FL, IL, CA OUS: None
- Lot, serial or model codes
- UDI: B098AMS130430/Lot #s: 178114 187325 191102 195504 196502 197864
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KDD
- 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