FDA recall Z-0029-2025

Windstone Medical Packaging, Inc. · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2024-08-16
Report date
2024-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Billings, MT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0029-2025