Windstone Medical Packaging, Inc. recalls Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a c…

Recall date

August 16, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0029-2025

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 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.