CLASS II ONGOING Device recall · Reported 16 Oct 2024 · FDA Enforcement Report

Aligned Medical Septo Pack recalled by Windstone Medical Packaging

Windstone Medical Packaging is recalling Aligned Medical Septo Pack, distributed nationwide in the US. The recall was initiated on 16 Aug 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273

Quantity recalled60 packs

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0029-2025
FDA event ID: 95306
Recalling firm: Windstone Medical Packaging, Billings, MT
Classification: Class II
Status: Ongoing
Recall initiated: 16 Aug 2024
FDA classified: 8 Oct 2024
Reported: 16 Oct 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Aug 2024	Recall initiated by company
8 Oct 2024	Classified by FDA	+53 days
16 Oct 2024	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to convenience kits containing a kit component that is under a recall action for improper use.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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.

Where it was distributed

U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Nationwide California Missouri Ohio Virginia Wyoming

Questions about this recall

Is Aligned Medical Septo Pack recalled?

Yes. Windstone Medical Packaging recalled Aligned Medical Septo Pack on 16 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-0029-2025.

Why was it recalled?

Due to convenience kits containing a kit component that is under a recall action for improper use.

Which lots are affected?

Catalog Number: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273

Where was it sold?

U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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5 Aug 2026Device	CLASS II	Ams Aligned Medical Solutions medical convenience kits recalled	Windstone Medical Packaging	Packaging Defects	Nationwide
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