Z-0028-2025 Class II Ongoing
FDA device recall Z-0028-2025 was initiated by Windstone Medical Packaging, Inc. on Aug 16, 2024 and is designated Class II. Reason for recall: Due to convenience kits containing a kit component that is under a recall action for improper use. The recall status is ongoing. Affected quantity: 894 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 16, 2024
- Initiation Date
- Aug 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 894 kits
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.
Reason for Recall
Due to convenience kits containing a kit component that is under a recall action for improper use.
Distribution Pattern
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Code Information
Catalog Number: AMS9977 UDI-DI code: B098AMS99770 Lot Numbers: 158265 164363 167626 169363 173648 178341 186343 192237 193165 194502 196521 201447 202990 205757 208807 210226 211594 212449
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0028-2025
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026