Z-0029-2025Class II

Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product...

Name: Z-0029-2025 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product...
Creator: Windstone Medical Packaging, Inc.
Published: 2024-08-16
License: https://open.fda.gov/license/

Windstone Medical Packaging, Inc. / initiated 2024-08-16 / Open, Classified

FDA source

Windstone Medical Packaging, Inc. began a recall of 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... on 2024-08-16. FDA classified it as Class II and gives the reason as "Due to convenience kits containing a kit component that is under a recall action for improper use". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0029-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-16
Posted: 2024-10-08
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.
Product code: OGR Ear, Nose, And Throat Surgical Tray
Reason for recall: Due to convenience kits containing a kit component that is under a recall action for improper use.
FDA 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 [email protected] even if you have no affected product on hand. For questions or concerns, contact Aligned Medical Solutions at [email protected]
Quantity in commerce: 60 packs
Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Product codes and lots: Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0029-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0027-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-08
Z-0028-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-08
Z-0029-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-08
Z-0030-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-08
Z-0031-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-16	2024-10-08

Product code OGR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)