FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0028-2025
·
Reported October 16, 2024
Enforcement
- Recall Number
- Z-0028-2025
- Event ID
- 95306
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Windstone Medical Packaging, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 16, 2024
- Initiation Date
- August 16, 2024
- Classification Date
- October 8, 2024
- Address
- 1602 4th Ave N, Billings, MT, 59101-1521, United States
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
Due to convenience kits containing a kit component that is under a recall action for improper use.
Code Info
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
Distribution
U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Quantity
894 kits