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.
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: 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.
- 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: AMS11480 UDI-DI code: B098AMS114800 Lot Numbers: 205273
Distribution
Distributed nationwide across the United States.
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