Aligned Medical Tonsil ENT Pack Recalled for Component Under Separate Recall
Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.
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 medical device recall with no reported illnesses or injuries. The recall is precautionary, initiated because a kit component is under a separate recall action.
Plain-English summary
Windstone Medical Packaging, Inc. is recalling the Aligned Medical Tonsil ENT Pack (Reference Number AMS9977). This medical device is a convenience kit designed for use in general clinical procedures and contains Cardinal Health Salem Sump PVC tubes.
The recall was initiated because the Salem Sump PVC tubes component is subject to a separate recall action due to improper use concerns. The affected kits bear lot numbers 158265, 164363, 167626, 169363, 173648, 178341, 186343, 192237, 193165, 194502, 196521, 201447, 202990, 205757, 208807, 210226, 211594, and 212449.
A total of 894 kits were distributed nationwide in the states of California, Missouri, Ohio, Virginia, and Wyoming.
The recalled product
- Product
- Aligned Medical Tonsil ENT Pack REF AMS9977 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 — ENT Surgical
- Hazard
- Affected units
- 894
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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