Device product
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Z-0027-2025
Product summary
- Event
- Event 95306
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 642 kits
- Official record key
device-enforcement:Z-0027-2025
Official wording
Reason: Due to convenience kits containing a kit component that is under a recall action for improper use.
Code information: Catalog Number: AMS9300A UDI-DI code: B098AMS9300A0 Lot Numbers: 168030 171362 172981 177913 179608 181537 185126 189873 189874 196460 196461 198850 200902 206846 208255 209391
Distribution pattern: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
Derived failure modes
-
Unknown
Due to convenience kits containing a kit component that is under a recall action for improper use.