FDA Medical Device Recalls (openFDA)
Windstone Medical Packaging, Inc.: Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Recall number
- Z-0029-2025
- Recalling firm
- Windstone Medical Packaging, Inc.
- Product
- Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
- Status
- Open, Classified
- Initiated
- 2024-08-16
- Posted
- 2024-10-08
- Terminated
- not on file
- Reason
- Due to convenience kits containing a kit component that is under a recall action for improper use.
- Root cause
- Use error
- Action
- On 08/16/2024, the firm email an "URGENT: MEDICAL DEVICE PRODUCT CORRECTION" Letter to customers informing them that Cardinal Health is conducting a product correction for its Salem Sump PVC Tubes. These Sump PVC tubes were included in the Aligned Medical convenience kits. The correction for this Recall is an updated product label, an electronic instruction for use (eIFU). The updated labeling is to address improper use of the Sump PVC tubes which can lead to breakage of the Salem Sump Anti Reflux Valve (ARV) that increases risk to patients. Customers are instructed to: 1. Review your inventory for the affected kits, all lots are impacted 2. Communicate the change to the use instructions with all personnel that utilize Salem Sump" products contained within AMS kits. 3. If you have further distributed this product, please identify your distribution partners, and notify them at once of the product correction. Your notification to your customers should include a copy of this notification letter. 4. Please complete and return the AMS Urgent Medical Device Product Correction Response Required form within 5 business days and return via email to fieldcorrectiveaction@alignedmedical.com even if you have no affected product on hand. For questions or concerns, contact Aligned Medical Solutions at fieldcorrectiveaction@alignedmedicalsolutions.com
- Quantity
- 60 packs
- Distribution
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
- Lot, serial or model codes
- Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGR
- 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