Class II

Medical Device Recall: 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.

Windstone Medical Packaging, Inc. · August 16, 2024

Reason for Recall

Due to convenience kits containing a kit component that is under a recall action for improper use.

Distribution

U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

States Affected

NATIONWIDE

Quantity Affected

60 packs

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0029-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.