Windstone Medical Packaging, Inc.: Device Recall

Recall #Z-0028-2025 · 08/16/2024

Class II: Risk

Recall Details

Recall Number
Z-0028-2025
Classification
Class II
Product Type
Device
Recalling Firm
Windstone Medical Packaging, Inc.
Status
Ongoing
Date Initiated
08/16/2024
Location
Billings, MT, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
894 kits

Reason for Recall

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

Product Description

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.

Distribution Pattern

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

Other Recalls by Windstone Medical Packaging, Inc.

View all recalls by Windstone Medical Packaging, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.