The Recall Desk
ModerateFDA (Devices)·Z-0030-2025·Announced 2024-10-16

Aligned Medical T and A Pack Recalled for Component Misuse Risk

Windstone Medical Packaging is recalling Aligned Medical T and A Pack REF AMS11482 because it contains a component subject to a separate recall action for improper use.

What this means for you

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: This is an FDA Class II recall with no reported illnesses or injuries. The recall is based on a component within the kit being subject to a separate recall action, representing a precautionary measure. The hazard related to improper use is theoretical with no confirmed patient harm.

Plain-English summary

Windstone Medical Packaging, Inc. is recalling the Aligned Medical T and A Pack (Catalog Number AMS11482, UDI-DI B098AMS114820, Lot Number 205275). This convenience kit is used in general clinical procedures and contains Cardinal Health Salem Sump PVC tubes.

The kit is being recalled because it contains a component that is subject to a separate recall action due to improper use.

The recalled packs were distributed nationwide in the United States in California, Missouri, Ohio, Virginia, and Wyoming. A total of 40 packs were distributed.

Healthcare facilities and clinicians who have received this product should cease use and contact the manufacturer for instructions on return or disposal.

The recalled product

Product
Aligned Medical T and A Pack REF AMS11482 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 — Surgical Convenience Kit
Hazard
Affected units
40

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: AMS11482 UDI-DI code: B098AMS114820 Lot Numbers: 205275

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 →

Related recalls

Same manufacturer · Windstone Medical Packaging, Inc.

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Same hazard · improper use

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