Medical device recalls Moderate risk

Windstone Medical Packaging, Inc. recalls Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…

Recall date
August 16, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0027-2025
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 Tray REF AMS9300A 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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