Windstone Medical Packaging, Inc. recalls Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in…
- Recall date
- August 16, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0028-2025
- FDA classification
- Class II
- Brand / firm
- Windstone Medical Packaging, Inc.
- Sold / distributed
- U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Why it was recalled
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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