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.
- Hazard
- improper-use
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.
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