The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0029-2025·Announced 2024-10-16

Aligned Medical Septo Pack recalled for containing component under FDA recall

The Aligned Medical Septo Pack (AMS11480) is recalled because it contains a Cardinal Health Salem Sump PVC tube component that is subject to an FDA recall for improper use.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is characterized as improper use of a kit component without specific safety consequences documented in the source, fitting the criteria for a moderate-severity recall.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling the Aligned Medical Septo Pack (Catalog Number AMS11480, UDI-DI: B098AMS114800) because it contains a Cardinal Health Salem Sump PVC tube component that is subject to a separate FDA recall action for improper use.

The Septo Pack is a convenience kit designed for use in general clinical procedures. The included Salem Sump PVC tubes are a key component of the kit and are the subject of the FDA recall.

The affected product was distributed nationwide in the United States to California, Missouri, Ohio, Virginia, and Wyoming. Approximately 60 packs were distributed with lot number 205273.

The recalled product

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.
Manufacturer
Windstone Medical Packaging, Inc.
Category
Medical Device — Clinical Procedure Kit
Hazard
Affected units
60

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 5 recalled by Windstone Medical Packaging, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

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