Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component
Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.
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: This is an FDA Class II medical device recall without any reported illnesses, injuries, or deaths. The recall is precautionary in nature, issued because a kit component is under a separate recall action for improper use. Per the severity rubric, Class II recalls without reported harm are classified as Moderate (score 2).
Plain-English summary
Windstone Medical Packaging, Inc. is recalling Aligned Medical Tonsil Pack kits (REF AMS14809) that contain Cardinal Health Salem Sump PVC tubes. The recall has been initiated because the kit contains a component under a separate recall action for improper use.
The affected medical device packs were distributed nationwide to healthcare facilities in California, Missouri, Ohio, Virginia, and Wyoming. A total of 180 packs have been distributed with the following lot numbers: 192737, 194922, 200224, 200950, and 203412.
Healthcare providers and medical facilities should identify and locate any affected inventory using the catalog number AMS14809 and the lot numbers listed above. Contact Windstone Medical Packaging, Inc. or the FDA for further instructions regarding return, replacement, or disposal of recalled products.
The recalled product
- Product
- Aligned Medical Tonsil Pack REF AMS14809 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
- Hazard
- Affected units
- 180
Distribution
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.
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